Attachment_1_Data_Documents.doc

Attachment 1: Data Documents

Data Documents for the CDx technology:

1. FDA CDx published documentation links:

a. FDA Licensing and Collaboration Opportunities announcement: “A Hand Held Portable Device Based on Light Emitting Diodes (LEDs) as a Light Source for Use in the Detection of Counterfeit Pharmaceutical Drugs and Packaging”, August 7 2015: http://www.fda.gov/scienceresearch/collaborativeopportunities/inventions/ucm464948.htm

b. FDA 2015 Science Writers Symposium:

i. “Creating FDA’s Visual Identity”: http://www.fda.gov/downloads/scienceresearch/meetingsconferencesandworkshops/sciencewriterssymposium/ucm467972.pdf

ii. “Support New Approaches to Improve Product Manufacturing and Quality”: http://www.fda.gov/downloads/scienceresearch/aboutscienceresearchatfda/ucm447461.pdf

2. AWARDS

a. FDA’s Commissioner’s Special Citation Award – Anti-Malarial Counterfeit FPIE Team

b. ORA’s Todd M. Bozicevich, ORA Education Collaboration of the Year Award for the IM214 CDx course

c. HHS Secretary’s pick for the HHSinnovates Award

3. DOING BUSINESS WITH FDA, “FDA Technology Transfer” by Office of Technology Transfer, July 16, 2015: http://www.fda.gov/aboutfda/business/ucm119486.htm

4. FDA NEWS AND EVENTS:

i. "Counterfeit Drugs: Fighting Illegal Supply Chains" by Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations and Policy, February 27, 2014: http://www.fda.gov/NewsEvents/Testimony/ucm387449.htm

ii. “Working Together to Address the Challenges of Rare and Neglected Diseases” by Jesse L. Goodman, M.D., M.P.H. FDA Chief Scientist, June 27, 2013: http://www.fda.gov/newsevents/testimony/ucm358834.htm

5. FDA NEWS RELEASE:

i. “MOU Between USAID and DHHS/FDA to Collaborate on Testing of the Counterfeit Detection Device”: http://www.fda.gov/aboutfda/partnershipscollaborations/memorandaofunderstandingmous/domesticmous/ucm466671.htm

ii. “FDA Partnership to Protect Against Counterfeit Anti-Malarial Drugs Media Briefing”: http://www.fda.gov/downloads/newsevents/newsroom/mediatranscripts/ucm349704.pdf

iii. “FDA launches partnership to protect against counterfeit anti-malarial medicines with FDA-developed handheld detection tool”: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm349195.htm

iv. “FDA Invention Fights Counterfeit Malaria Drugs”: http://www.fda.gov/downloads/forconsumers/consumerupdates/ucm349206.pdf

b. FDA Facts: “FDA’s Counterfeit Detection Device CD-3” announcement: http://www.fda.gov/downloads/newsevents/newsroom/factsheets/ucm349286.pdf

c. FDA’s CDx video, “CD-3: A New Tool in FDA's Fight Against Counterfeit Products”: http://www.youtube.com/watch?v=mfYUkiKAJvA

6. ABOUT FDA:

a. “Strategic Priorities: Cross-Cutting Strategic Priorities”, April 21, 2011: http://www.fda.gov/aboutfda/reportsmanualsforms/reports/ucm246737.htm

7. Publications:

a. Batson JS, Bempong DK, Lukulay PH, Ranieri N, Satzger RD, Verbois L. “Assessment of the effectiveness of the CD3+ tool to detect counterfeit and substandard anti-malarials”; Malar J 2016 Feb 25;15(1):119; http://www.accessdata.fda.gov/scripts/publications/search_result_record.cfm?id=54691

b. Alexandra Ossola, “The Fake Drug Industry Is Exploding, and We Can’t Do Anything About It”; September 17, 2015: http://www.newsweek.com/2015/09/25/fake-drug-industry-exploding-and-we-cant-do-anything-about-it-373088.html

c. Margaret Hamburg, Former Commissioner, U.S. Food and Drug Administration, “The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Implications”; Am. J. Trop. Med. Hyg., 92(Suppl 6), 2015, p. 1 doi:10.4269/ajtmh.15-0046: http://www.ajtmh.org/content/92/6_Suppl/1.full?sid=a3b794c8-ce86-4001-a04d-23d70deaf149

d. Patricia Tabernero,* Mayfong Mayxay, Marı´a Julia Culzoni, Prabha Dwivedi, Isabel Swamidoss, Elizabeth Louise Allan, Maniphone Khanthavong, Chindaphone Phonlavong, Chantala Vilayhong, Sengchanh Yeuchaixiong, Chanvilay Sichanh, Sivong Sengaloundeth, Harparkash Kaur, Facundo M. Ferna´ndez, Michael D. Green, and Paul N. Newton. “A Repeat Random Survey of the Prevalence of Falsified and Substandard Antimalarials in the Lao PDR: A Change for the Better”; Am. J. Trop. Med. Hyg., 92(Suppl 6), 2015, pp. 95–104 doi:10.4269/ajtmh.15-0057: http://www.ajtmh.org/content/92/6_Suppl/95.full?sid=c2a713d7-4962-4725-8a63-484b18d1b618#T2

e. Gawvika M. L. Nayyar, Amir Attaran, John P. Oark, M. Julia Culzoni, Facundo M. Fernandez, James E. Herrington, Megan Kendall, Paul N. Newton, and Joel G. Breman “Responding to the Pandemic of Falsified Medicines”; Amer.J.Trop.Med.Hyg., 92(Supp16), 2015, pp. 113-118 doi:10.4269/ajtmh.14-0393: http://www.ajtmh.org/content/92/6_Suppl/113.full.pdf+html?sid=0bfe25e1-6297-479d-9966-6dbcacac66ea

f. Adam Lanzarotta, Nicola Ranieri, Douglas C. Albright, Mark R. Witkowski, JaCinta S. Batson, and Moseley Fulcher. “Analysis of Counterfeit FDA-Regulated Products at the Forensic Chemistry Center: Rapid Visual and Chemical Screening Procedures Inside and Outside of the Laboratory”: Amer Pharm Review J, May 20, 2015: http://www.americanpharmaceuticalreview.com/Featured-Articles/174391-Analysis-of-Counterfeit-FDA-Regulated-Products-at-the-Forensic-Chemistry-Center-Rapid-Visual-and-Chemical-Screening-Procedures-Inside-and-Outside-of-the-Laboratory/

g. Green MD, Hostetler DM, Nettey H, Swamidoss I, Ranieri N, Newton PN. “Integration of Novel Low-cost Colorimetric, Laser Photometric and Visual Fluorescent Techniques for Rapid Identification of Falsified Medicines in Resource-poor Areas: Application to Artemetherlumefantrine”. Am. J. Trop. Med. Hyg., 92(Suppl 6), 2015, pp. 8–16 doi:10.4269/ajtmh.14-0832; http://www.ajtmh.org/content/92/6_Suppl/8.full?sid=7b7cea9e-03ca-4d7c-9124-e39c2d52875f

h. Paul N Newton, Patricia Tabernero, Prabha Dwivedi, María J Culzoni, María Eugenia Monge, Isabel Swamidoss, Dallas Mildenhall, Michael D Green, Richard Jähnke, Miguel dos Santos de Oliveira, Julia Simao, Nicholas J White, Facundo M Fernández. “Falsified medicines in Africa: all talk, no action” Lancet: http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(14)70279-7/fulltext?elsca1=&elsca2=email&elsca3=

i. Ranieri N, Tabernero P, Green MD, Verbois L, Herrington J, Sampson E, Satzger RD, Phonlavong C, Thao K, Newton PN, Witkowski MR. “Evaluation of a New Handheld Instrument for the Detection of Counterfeit Artesunate by Visual Fluorescence Comparison”. Amer J Trop Med Hyg 2014 Nov 5;91(5):920-4: http://www.ajtmh.org/content/91/5/920.full?sid=0bfe25e1-6297-479d-9966-6dbcacac66ea and PubMed journal: http://www.ncbi.nlm.nih.gov/pubmed/25266348