Attachment H Resources FED27June2022.pdf

Attachment H

Federal Resources

Figure 1. Federal Leaflet

Prescribing Information and Application Holder Responsibilities

The Prescribing Information is written for the healthcare practitioner and must:

• Contain a summary of essential scientific information needed for safe and effective use of the human prescription drug or biological product.

• Be informative and accurate and neither promotional in tone nor false or misleading

• Be updated when new information becomes available that causes labeling to become inaccurate, false, or misleading

Application holders should review PI at least annually for outdated information.

Prescribing Information Requirements and Rules

• Physician Labeling Rule: This January 2006 final rule revised the content and format of PI for human prescription drugs, including biological products.

• 21 CFR 201.56: General requirements on the content and format of PLR format labeling and “old” format (non-PLR) labeling

• 21 CFR 201.57: Specific requirements on content and format of PLR format labeling for human prescription drugs, including biological products

• Pregnancy and Lactation Labeling RuleExternal Link Disclaimer: This December 2014 final rule revised the content and format of pregnancy, lactation, and females and males of reproductive potential information in labeling

• 21 CFR 201.80: Specific requirements on content and format of “old” format (non-PLR) labeling for human prescription drugs, including biological products

Broad Labeling Resources

• Implementing the PLR Content and Format Requirements (final guidance)

• Voluntary PLR Conversions and Updating Prescribing Information (2019 presentation and videoExternal Link Disclaimer)

• Improving Consistency of Information Between Carton-Container Labeling and Prescribing Information (2019 presentation and videoExternal Link Disclaimer)

• Drugs@FDA vs. DailyMed, Labeling Resources, and Future Labeling Guidances (2019 presentation)

• CDER’s Review of the Prescribing Information (2019 presentation)

• Updating Prescription Drug and Biological Product Labeling (2018 presentation)

• Consistency in Labeling and Methods to Optimize Communication in

Labeling (2017 presentation)

• Converting Labeling for Older Drugs from Old Format to PLR Format

(2017 presentation) (videoExternal Link Disclaimer)

• PLR Implementation, CDER Staff for Labeling Review, and Labeling

Resources (2017 presentation) (videoExternal Link Disclaimer)

• CDER's Review of Prescribing Information (2017 presentation)

• Prescribing Information - Resources and Review Process (2016 presentation)

• Highlights of Prescribing Information (2015 presentation)

• Prescribing Information Potpourri (2015 presentation)

Indications and Usage, Dosage and Administration, and Clinical Studies Information in Labeling https://www.govinfo.gov/content/pkg/FR-2006-01-24/pdf/06-545.pdf http://www.ecfr.gov/cgi-bin/text-idx?SID=5408745407b957e41743749a0425e278&mc=true&node=se21.4.201_156&rgn=div8 http://www.ecfr.gov/cgi-bin/text-idx?SID=467396391e8b4b96742e806bf1c0b8e7&mc=true&node=se21.4.201_157&rgn=div8 https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-28241.pdf http://www.fda.gov/about-fda/website-policies/website-disclaimer http://www.ecfr.gov/cgi-bin/text-idx?SID=436dac3629ae302b6140a408c19141d0&mc=true&node=se21.4.201_180&rgn=div8 https://www.fda.gov/media/71836/download https://www.fda.gov/media/71836/download https://www.fda.gov/media/134011/download https://concerted.adobeconnect.com/pkldoq6dkdcr/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/134012/download https://concerted.adobeconnect.com/p02pkgp4cw75/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/128451/download https://www.fda.gov/media/128451/download https://www.fda.gov/media/127595/download https://www.fda.gov/media/127182/download https://www.fda.gov/media/127182/download https://www.fda.gov/media/109311/download https://www.fda.gov/media/109311/download https://www.fda.gov/media/109318/download https://www.fda.gov/media/109318/download https://concerted.adobeconnect.com/picny9dttw0g/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/109323/download https://www.fda.gov/media/109323/download https://concerted.adobeconnect.com/pysx8iu0lclv/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/103724/download https://www.fda.gov/media/100510/download https://www.fda.gov/media/100510/download https://www.fda.gov/media/96632/download https://www.fda.gov/media/97736/download

• Indications and Usage Section of Labeling (draft guidance)

• Indications and Usage Section of Labeling Draft

Guidance (2019 presentation and videoExternal Link Disclaimer)

• Considerations for Developing Indications and Usage Section (2017 presentation) (videoExternal Link Disclaimer)

• Indications and Usage Section (2015 presentation)

• Labeling Case Study - Transformation of an Indication

(2019 presentation and videoExternal Link Disclaimer)

• Labeling for Human Prescription Drug and Biological Products Approved

Under the Accelerated Approval Regulatory Pathway (final guidance)

• Limited Population Pathway for Antibacterial and Antifungal Drugs (final guidance) NEW!

• Dosage and Administration Section of Labeling (final guidance)

• Dosage and Administration Section (2015 presentation)

• Clinical Studies Section of Labeling (final guidance)

• Considerations for the Clinical Studies Section of Labeling (2017 presentation)

• Clinical Studies Section (2015 presentation)

Pregnancy, Lactation, and Females and Males of Reproductive Potential Information in Labeling

• Pregnancy and Lactation Labeling RuleExternal Link Disclaimer (PLLR): This December 2014 final rule revised the content and format of pregnancy, lactation, and females and males of reproductive potential information in labeling

• Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format (draft guidance) NEW!

• Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations (final guidance)

• PLLR: Four Years In – What’s Next? (2019 presentation)

• PLLR: Two Years In – Incorporating Human Pregnancy Data in Labeling

(2017 presentation)

• The Pregnancy and Lactation Labeling Rule (2016 presentation)

• PLLR implementation schedule

• Additional PLLR Resources: Labeling for use of prescription drugs, including biological products, during pregnancy, during lactation, and in females and males of reproductive potential

Pediatric, Geriatric, and Other Specific Population Information in Labeling

• Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling (final guidance) https://www.fda.gov/media/114443/download https://www.fda.gov/media/133939/download https://concerted.adobeconnect.com/poa4enixbmf8/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/109300/download https://www.fda.gov/media/109300/download https://concerted.adobeconnect.com/pxdsnlqaswg2/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/96640/download https://www.fda.gov/media/133938/download https://concerted.adobeconnect.com/p7ior9me4fvh/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/119755/download https://www.fda.gov/media/119755/download https://www.fda.gov/media/113729/download https://www.fda.gov/media/113729/download https://www.fda.gov/media/72142/download https://www.fda.gov/media/96647/download https://www.fda.gov/media/72140/download https://www.fda.gov/media/127594/download https://www.fda.gov/media/127594/download https://www.fda.gov/media/96133/download https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-28241.pdf http://www.fda.gov/about-fda/website-policies/website-disclaimer http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/90160/download https://www.fda.gov/media/90160/download https://www.fda.gov/media/90160/download https://www.fda.gov/media/124829/download https://www.fda.gov/media/124829/download https://www.fda.gov/media/135694/download https://www.fda.gov/media/111774/download https://www.fda.gov/media/111774/download https://www.fda.gov/media/100406/download https://www.fda.gov/media/134019/download https://www.fda.gov/drugs/labeling/pregnancy-and-lactation-labeling-drugs-final-rule https://www.fda.gov/media/84949/download https://www.fda.gov/media/84949/download

• Pediatric Information in Labeling (2019 presentation and videoExternal Link Disclaimer)

• Geriatric Information in Human Prescription Drug and Biological Product Labeling (draft guidance) NEW!

• Promoting Safe and Effective Prescription Drug Use in Geriatric Patients (2020 presentationExternal Link Disclaimer and videoExternal Link Disclaimer) NEW!

• Distributing Specific Population Information in Labeling (2015 presentation)

Safety-Related Information in Labeling

• Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling (final guidance)

• Adverse Reactions Section of Labeling (final guidance)

• Adverse Reaction Information in Labeling

(2019 presentation and videoExternal Link Disclaimer)

• Safety-Related Information in the Prescribing Information (2015 presentation)

• Drug Abuse and Dependence Section of Labeling (draft guidance)

• Drug Abuse and Dependence Section of Labeling Draft Guidance

(2019 presentation and videoExternal Link Disclaimer)

• Abuse-Deterrent Opioids - Evaluation and Labeling (final guidance)

• Best Practices in Developing Proprietary Names for Drugs (draft guidance)

• Safety Labeling Changes - Implementation of Section 505(o)(4) of the

FDC Act (final guidance)

• Safety Labeling Changes Under Section 505(o)(4) of the FD&C Act

(MAPP)

• Public Availability of Labeling Changes in “Changes Being Effected”

Supplements (draft guidance)

• Drug Safety-Related Labeling Changes Database - provides recent updates on safety information in labeling. This database includes labeling changes (1) from labeling and efficacy supplement approvals and

(2) required by the FDA under Section 505(o)(4) of the FD&C Act (safety labeling changes).

• Drug Safety Communications – contains the most recent Drug Safety Communications from FDA

Clinical Pharmacology Information in Labeling

• Labeling Made Simple: The How, What, and Where of Drug Interactions in Prescribing Information (2020 presentation and video).

• Describing Clinically Significant Drug Interactions in the Warnings and Precautions Section (2015 presentation) https://www.fda.gov/media/133941/download https://concerted.adobeconnect.com/prjmgqesjalt/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/142162/download https://www.fda.gov/media/142162/download https://sbiaevents.com/files2/SBIA-Geriatrics-Labeling-Webinar.pdf http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.bing.com/videos/search?q=sbia+fda+eric+brodsky&&view=detail&mid=DD0674249261BC48FDA5DD0674249261BC48FDA5&&FORM=VRDGAR&ru=%2Fvideos%2Fsearch%3Fq%3Dsbia%2520fda%2520eric%2520brodsky%26qs%3Dn%26form%3DQBVR%26sp%3D-1%26pq%3Dsbia%2520fda%2520eric%2520brods%26sc%3D0-19%26sk%3D%26cvid%3D1BC51CD334324001A75B757ED10F2A0C http://www.fda.gov/about-fda/website-policies/website-disclaimer http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/96127/download https://www.fda.gov/media/96127/download https://www.fda.gov/media/71866/download https://www.fda.gov/media/71866/download https://www.fda.gov/media/72139/download https://www.fda.gov/media/133940/download https://concerted.adobeconnect.com/pf3v61uvw65t/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/96657/download https://www.fda.gov/media/96657/download https://www.fda.gov/media/128443/download https://www.fda.gov/media/133942/download https://concerted.adobeconnect.com/poa4enixbmf8/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/84819/download https://www.fda.gov/files/drugs/published/Best-Practices-in-Developing-Proprietary-Names-for-Drugs.pdf https://www.fda.gov/files/drugs/published/Best-Practices-in-Developing-Proprietary-Names-for-Drugs.pdf https://www.fda.gov/media/116594/download https://www.fda.gov/media/116594/download https://www.fda.gov/media/128660/download https://www.fda.gov/media/128660/download https://www.fda.gov/media/71848/download https://www.fda.gov/media/71848/download https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/ https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications https://www.fda.gov/media/143285/download https://collaboration.fda.gov/plj37w5ktk5u/?proto=true https://www.fda.gov/media/101611/download https://www.fda.gov/media/101611/download

• Clinical Drug Interaction Studies - Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions (final guidance) NEW!

• Clinical Pharmacology Section of Labeling (final guidance)

• A Recipe for Clinical Pharmacology Information in Labeling

(2019 presentation and videoExternal Link Disclaimer)

• The Ins and Outs of Presenting Clinical Pharmacology Information in

Prescription Drug Labeling (2017 webinar)

• Cracking the Code for Clinical Pharmacology-Related Prescription Drug

Labeling (2017 presentation) (videoExternal Link Disclaimer)

• Strategies for Enhancing Quality, Utility, & Clarity in Clinical

Pharmacology-Related Labeling (2017 presentation)

• Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical

Pharmacology Considerations (draft guidance)

• Pharmacokinetics in Patients with Impaired Renal Function - Study

Design, Data Analysis, and Impact on Dosing (draft guidance) NEW!

• Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase

Clinical Studies and Recommendations for Labeling (final guidance)

Microbiology Information in Labeling

• Limited Population Pathway for Antibacterial and Antifungal Drugs (final guidance) NEW!

• Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation (final guidance)

• Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs (final guidance)

Sample Templates and Format Tools for Prescribing Information

• Final Labeling Check of Labeling Format and Appearance (2019 presentation and videoExternal Link Disclaimer)

• Recommendations for Final Labeling Format Check Prior to End-of-Cycle Labeling Submission

• Sample PLR Template - Highlights, Contents, and Full Prescribing Information

• Selected Requirements of Prescribing Information (SRPI) - A 41-item, drop-down checklist of important format elements of the PI based on regulations (21 CFR 201.56 and 201.57) and guidances

• SRPI Video - Highlights

• SRPI Video - Table of Contents and Full Prescribing Information

Established Pharmacologic Class (EPC) Resources

• Determining the EPC for Use in Highlights MAPP https://www.fda.gov/media/134581/download https://www.fda.gov/media/134581/download https://www.fda.gov/media/74346/download https://www.fda.gov/media/133943/download https://concerted.adobeconnect.com/phemdshxo9yf/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/drugs/cder-small-business-and-industry-assistance/cder-small-business-and-industry-assistance-cder-sbia-webinar-ins-and-outs-presenting-clinical https://www.fda.gov/drugs/cder-small-business-and-industry-assistance/cder-small-business-and-industry-assistance-cder-sbia-webinar-ins-and-outs-presenting-clinical https://www.fda.gov/media/109306/download https://concerted.adobeconnect.com/pbofonul54ko/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/100521/download https://www.fda.gov/media/100521/download https://www.fda.gov/media/121313/download https://www.fda.gov/media/121313/download https://www.fda.gov/media/78573/download https://www.fda.gov/media/78573/download https://www.fda.gov/media/84923/download https://www.fda.gov/media/84923/download https://www.fda.gov/media/113729/download https://www.fda.gov/media/113729/download https://www.fda.gov/media/77442/download https://www.fda.gov/media/77442/download https://www.fda.gov/media/109839/download https://www.fda.gov/media/109839/download https://www.fda.gov/media/134013/download https://concerted.adobeconnect.com/pszob76p551w/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/116903/download https://www.fda.gov/media/116903/download https://www.fda.gov/media/85262/download https://www.fda.gov/media/85262/download https://www.fda.gov/media/87094/download https://www.fda.gov/media/109337/download https://www.fda.gov/media/109351/download https://www.fda.gov/media/86437/download

• Determining the EPC for Use in Highlights Guidance

• FDA EPC Text Phrases for Indications and Usage heading in Highlights

(updated October 2021) NEW!

Generic Drug Products -Specific Labeling Resources

• Orange Book

• Updating ANDA Labeling After the Marketing Application for the RLD

Has Been Withdrawn (draft guidance)

• Acceptability of Draft Labeling to Support ANDA Approval (final guidance)

• Referencing Approved Drug Products in ANDA Submissions (final guidance)

• Determining Whether to Submit an ANDA or a 505(b)(2) Application

(final guidance)

• Good ANDA Submission Practices (draft guidance)

Biological Product-Specific Labeling Resources

• Labeling for Biological Products (2019 presentation and videoExternal Link Disclaimer)

• Labeling for Biosimilar Products (final guidance)

• Labeling for Biosimilar Products (2019 presentation)

• Biosimilar Product Information: Includes links to FDA-approved labeling for licensed biosimilar products.

• Nonproprietary Naming of Biological Products (final guidance)

• Nonproprietary Naming of Biological Products: Update (draft guidance)

• Procedures for Handling Requests for Nonproprietary Name Suffix

Review for Biological Products Newly Licensed Under Section 351of the PHS Act MAPP

• The “Deemed to be a License” Provision of the BPCI Act - Questions and Answers (final guidance) NEW!

• Products That Were Deemed to be BLAs on March 23, 2020 NEW!

• The Purple Book

Product Quality-Related Labeling Resources

• Considerations for Product Quality Information in Prescribing Information (2017 presentation)

• Product Title and Initial U.S. Approval in the Highlights of Prescribing Information (2019 presentation and videoExternal Link Disclaimer)

• Drug Product Nomenclature (2019 presentation and videoExternal Link Disclaimer)

• Product Title and Initial U.S. Approval in the Highlights of Prescribing Information (draft guidance) https://www.fda.gov/media/77834/download https://www.fda.gov/media/152880/download https://www.fda.gov/media/152880/download https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm https://www.fda.gov/media/99041/download https://www.fda.gov/media/99041/download https://www.fda.gov/media/93971/download https://www.fda.gov/media/93971/download https://www.fda.gov/media/102360/download https://www.fda.gov/media/102360/download https://www.fda.gov/media/124848/download https://www.fda.gov/media/124848/download https://www.fda.gov/media/110689/download https://www.fda.gov/media/134014/download https://concerted.adobeconnect.com/pwxpkukzgnmu/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/96894/download https://www.fda.gov/media/128461/download https://www.fda.gov/drugs/biosimilars/biosimilar-product-information https://www.fda.gov/media/93218/download https://www.fda.gov/media/121316/download https://www.fda.gov/media/123894/download https://www.fda.gov/media/123894/download https://www.fda.gov/media/123894/download https://www.fda.gov/media/135838/download https://www.fda.gov/media/135838/download https://www.fda.gov/media/119229/download https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/purple-book-lists-licensed-biological-products-reference-product-exclusivity-and-biosimilarity-or https://www.fda.gov/media/115378/download https://www.fda.gov/media/115378/download https://www.fda.gov/media/133937/download https://concerted.adobeconnect.com/pl9xkw3flx7z/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/134015/download https://concerted.adobeconnect.com/p9cftmxuebnq/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/110453/download https://www.fda.gov/media/110453/download

• Example Product Titles in Highlights of Prescribing Information NEW!

• Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (final guidance)

• Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation (final guidance)

• Naming of Drug Products Containing Salt Drug Substances (final guidance)

• Naming of Drug Products Containing Salt Drug Substances MAPP

• Quality Attribute Considerations for Chewable Tablets (final guidance)

• Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex (final guidance)

• Child-Resistant Packaging Statements in Drug Product Labeling (final guidance)

• Gluten in Drug Products and Associated Labeling Recommendations (draft guidance)

• Liposome Drug Products: Chemistry, Manufacturing, and Controls;

Human Pharmacokinetics and Bioavailability; and Labeling Documentation (final guidance)

• Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations (draft guidance)

• Use of Liquids and/or Soft Foods as Vehicles for Drug Administration:

General Considerations for Selection and In Vitro Methods for Product Quality Assessments (draft guidance)

• Best Practices in Developing Proprietary Names for Drugs (draft guidance)

• Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (final guidance)

• Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process (draft guidance)

• Transdermal and Topical Delivery Systems - Product Development and Quality Considerations (draft guidance)

Carton and Container Labeling Specific Resources

• Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products (final guidance)

• Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers (draft guidance)

• Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy (final guidance)

• Bar Code Label Requirements Questions and Answers (final guidance)

• Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (draft guidance) https://www.fda.gov/media/111445/download https://www.fda.gov/media/117883/download https://www.fda.gov/media/117883/download https://www.fda.gov/media/117883/download https://www.fda.gov/media/117883/download https://www.fda.gov/media/81626/download https://www.fda.gov/media/81626/download https://www.fda.gov/media/87247/download https://www.fda.gov/media/87247/download https://www.fda.gov/media/85022/download https://www.fda.gov/media/98598/download https://www.fda.gov/media/85473/download https://www.fda.gov/media/85473/download https://www.fda.gov/media/85473/download https://www.fda.gov/media/129881/download https://www.fda.gov/media/129881/download https://www.fda.gov/media/116958/download https://www.fda.gov/media/116958/download https://www.fda.gov/media/70837/download https://www.fda.gov/media/70837/download https://www.fda.gov/media/70837/download https://www.fda.gov/media/70851/download https://www.fda.gov/media/70851/download https://www.fda.gov/media/114872/download https://www.fda.gov/media/114872/download https://www.fda.gov/media/114872/download https://www.fda.gov/media/88496/download https://www.fda.gov/media/88496/download https://www.fda.gov/media/116720/download https://www.fda.gov/media/116720/download https://www.fda.gov/media/128689/download https://www.fda.gov/media/128689/download https://www.fda.gov/media/132674/download https://www.fda.gov/media/132674/download https://www.fda.gov/media/88138/download https://www.fda.gov/media/88138/download https://www.fda.gov/media/116304/download https://www.fda.gov/media/116304/download https://www.fda.gov/media/106198/download https://www.fda.gov/media/106198/download https://www.fda.gov/media/81277/download https://www.fda.gov/media/85879/download https://www.fda.gov/media/85879/download

• Safety Considerations for Carton and Container Labeling (2019 presentation and videoExternal Link Disclaimer)

• Improving Consistency of Information Between Carton-Container Labeling and Prescribing Information (2019 presentation and videoExternal Link Disclaimer)

Patient Labeling Specific Resources

• Instructions for Use - Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products (draft guidance) - Instructions for Use (IFU) are a type of FDA-approved patient labeling for drugs that have complicated or detailed patient-use instructions. The IFU provides detailed, action-oriented, step-by-step written and visual instructions for the patient on how to use the drug including instructions on preparation, administration, handling, storage, and disposal.

• Instructions for Use Draft Guidance (2019 presentation and videoExternal Link Disclaimer)

• Medication Guides: Medication Guides are a type of FDA-approved patient labeling for drugs used primarily on an outpatient basis when the FDA determines that it is necessary for patient’s safe and effective use.

• 21 CFR 208: Medication Guide regulations

• Patient Package Inserts (PPIs) are a type of FDA-approved patient labeling that are required for oral contraceptives (21 CFR 310.501) and estrogen-containing products (21 CFR 310.515). PPIs are voluntary for other prescription drug products.

Structured Product Labeling Resources

• Logical Observation Identifiers Names and Codes (LOINC) for Human Prescription Drug and Biological Product Labeling: For human prescription drugs, including biological products, this document links LOINC codes and names to (1) sections and subsections of PLR and “old” format labeling, (2) types of FDA-approved patient labeling, and (3) the principal display panel

• Improving the Accuracy of Structured Product Labeling (SPL) Submissions – The Missing LOINC (2019 presentation and videoExternal Link Disclaimer)

• Electronic Drug Registration and Listing Instructions

• Additional SPL Resources: SPL is the standard format for electronic submission of the content of labeling

Labeling-Related Databases https://www.fda.gov/media/134017/download https://concerted.adobeconnect.com/p1eyc2kzk7ji/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/134012/download https://concerted.adobeconnect.com/p02pkgp4cw75/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/128446/download https://www.fda.gov/media/128446/download https://www.fda.gov/media/128446/download https://www.fda.gov/media/134018/download https://concerted.adobeconnect.com/p3w7ehyump78/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=medguide.page&utm_campaign=SBIA%3A%20FDA%20Launches%20New%20Medication%20Guide%20Database&utm_medium=email&utm_source=Eloqua https://www.ecfr.gov/cgi-bin/text-idx?SID=392707447e0ef5e1d96bfe684c69a7a5&mc=true&tpl=/ecfrbrowse/Title21/21cfr208_main_02.tpl https://www.ecfr.gov/cgi-bin/text-idx?SID=6cf9ed76e9f41125dc3bfbe1a6dca505&mc=true&node=se21.5.310_1501&rgn=div8 https://www.ecfr.gov/cgi-bin/text-idx?SID=6cf9ed76e9f41125dc3bfbe1a6dca505&mc=true&node=se21.5.310_1515&rgn=div8 https://www.fda.gov/media/114007/download https://www.fda.gov/media/114007/download https://www.fda.gov/media/134020/download https://concerted.adobeconnect.com/psd39bvsd8wv/?launcher=false&fcsContent=true&pbMode=normal http://www.fda.gov/about-fda/website-policies/website-disclaimer http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/drugs/drug-registration-and-listing-system-drls-and-edrls/electronic-drug-registration-and-listing-instructions https://www.fda.gov/industry/fda-data-standards-advisory-board/structured-product-labeling-resources

• Drugs@FDA - includes information about drugs, including biological products, approved for human use in the United States (e.g., product information, regulatory history, most recent FDA-approved Prescribing Information and patient labeling, and reviews by FDA staff that evaluate the safety and effectiveness of the product). Drugs@FDA does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research or products not approved by the FDA.

• DailyMed - NIH’s labeling search tool over 130,000 labeling documents for prescription drugs (including biological products, vaccines, blood products, cellular and gene therapy products), over-the-counter drugs, homeopathic drugs, animal drugs, and other products.

• FDALabel - FDA’s labeling search tool over 130,000 labeling documents.

FDALabel and DailyMed have the same database but have different search functions and different displays of search results.

• Pediatric Labeling Information Database - highlights important labeling changes related to pediatric use.

• Drug Safety-Related Labeling Changes Database - provides recent updates on safety information in labeling. This database includes labeling changes (1) from labeling and efficacy supplement approvals and (2) required by the FDA under Section 505(o)(4) of the FD&C Act (safety labeling changes).

• National Drug Code (NDC) Directory – search for NDC codes

• Medication Guides

• Orange Book

• Products That Were Deemed to be BLAs on March 23, 2020

• Biosimilar Product Information

• The Purple Book

• CDER’s Novel Drugs and Biological Products

• CBER’s Novel Biological Products

Additional Labeling Resources

• Patient Counseling Information Section of Labeling (final guidance)

• Patient Counseling Information Section (2015 presentation)

• Medical Product Communications That Are Consistent With the FDA-

Required Labeling - Questions and Answers (final guidance)

• Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal FD&C Act (final guidance)

• Importation of Prescription Drugs (final rule) - 85 FR 62094

• CDER Manual of Policies and Procedures (MAPP): MAPPs establish a system for issuing directives in the Center for Evaluation and Research (CDER) to document and disseminate CDER policies and procedures.

• FDA Guidances: Refer to this page for other guidances that contain labeling recommendations and product-specific guidances.

• Labeling Policy Team in the Office of New Drugs at the FDA http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm https://dailymed.nlm.nih.gov/dailymed/index.cfm https://www.fda.gov/science-research/bioinformatics-tools/fdalabel-full-text-search-drug-product-labeling https://www.accessdata.fda.gov/scripts/sda/sdnavigation.cfm?sd=labelingdatabase https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/ https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=medguide.page&utm_campaign=SBIA%3A%20FDA%20Launches%20New%20Medication%20Guide%20Database&utm_medium=email&utm_source=Eloqua https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm https://www.fda.gov/media/119229/download https://www.fda.gov/drugs/biosimilars/biosimilar-product-information https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/purple-book-lists-licensed-biological-products-reference-product-exclusivity-and-biosimilarity-or https://www.fda.gov/drugs/development-approval-process-drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biological-approvals-year https://www.fda.gov/media/86734/download https://www.fda.gov/media/96136/download https://www.fda.gov/media/102575/download https://www.fda.gov/media/102575/download https://www.fda.gov/media/133646/download https://www.fda.gov/media/133646/download https://www.fda.gov/media/133646/download https://www.govinfo.gov/content/pkg/FR-2020-10-01/pdf/2020-21522.pdf https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp https://www.fda.gov/guidances-drugs https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/labeling-policy-team

Articles with Labeling Content

• Gassman, A. L, Nguyen, C. P., and Joffe, H. V. (2017). FDA Regulation of Prescription Drugs. The New England Journal of Medicine, 376: 674-

82. https://www.nejm.org/doi/10.1056/NEJMra1602972External Link Disclaimer

• Balogh EP, Bindman AB, Eckhardt SG, Halabi S, Harvey RD, Jaiyesimi I, Miksad R, Moses HL, Nass SJ, Schilsky RL, Sun S, Torrente JM, and Warren KE. (2019). Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs. The Oncologist, 24:1–

7. https://theoncologist.onlinelibrary.wiley.com/doi/10.1634/theoncolog ist.2019-0698External Link Disclaimer

• Guinn, D., Madabushi, R., Wang, Y., Brodsky, E., Zineh, I., and Maxfield, K. Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation. Ther Innov Regul Sci (2020). https://doi.org/10.1007/s43441-020-00161-zExternal Link Disclaimer

Healthcare Practitioner Labeling Resources

• Labeling Made Simple: The How, What, and Where of Drug Interactions in Prescribing Information (2020 presentation and video).

• Labeling on Drugs@FDA vs. DailyMed (2017 presentation)

• Professional Labeling: The Prescribing Information (2015 presentation)External Link Disclaimer

Questions For general questions about the Prescribing Information or this website see the Labeling Policy Team webpage and for specific questions about labeling under an NDA, BLA, or ANDA please contact the regulatory project manager assigned to the application.

https://www.nejm.org/doi/10.1056/NEJMra1602972 http://www.fda.gov/about-fda/website-policies/website-disclaimer http://www.fda.gov/about-fda/website-policies/website-disclaimer https://theoncologist.onlinelibrary.wiley.com/doi/10.1634/theoncologist.2019-0698 https://theoncologist.onlinelibrary.wiley.com/doi/10.1634/theoncologist.2019-0698 http://www.fda.gov/about-fda/website-policies/website-disclaimer https://doi.org/10.1007/s43441-020-00161-z http://www.fda.gov/about-fda/website-policies/website-disclaimer http://www.fda.gov/about-fda/website-policies/website-disclaimer https://www.fda.gov/media/143285/download https://collaboration.fda.gov/plj37w5ktk5u/?proto=true https://www.fda.gov/media/127183/download https://wayback.archive-it.org/7993/20161022171137/http:/www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/ucm419336.htm https://wayback.archive-it.org/7993/20161022171137/http:/www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/ucm419336.htm http://www.fda.gov/about-fda/website-policies/website-disclaimer