This federal contract award, with ID 75F40122C00192, was issued by the Food and Drug Administration (FDA) to the National Institute for Pharmaceutical Technology & Education Inc. (Nipte), a non-profit organization. The $3,000,000.00 cost-no-fee contract is for continuous drug substance manufacturing from biomass-derived building blocks, in support of the FDA's effort to advance regulatory science. This contract was awarded under the FDA's Broad Agency Announcement mechanism, which solicits...
The Department of Health and Human Services (HHS) Food and Drug Administration (FDA) awarded a $743,717.94 Definitive Contract to the National Institute For Pharmaceutical Technology & Education Inc. (Nipte), a non-profit organization, to conduct research and development on the assessment of smoking and vaping risk of opioids and commercial products, as well as the standardization of methods to assess these properties. This contract was issued under the FDA's Broad Agency Announcement...
This is a $1,904,355.00 definitive cost-no-fee contract awarded by the Food and Drug Administration (FDA), a civilian government agency, to the Institute Of Quantitative Systems Pharmacology, a non-profit organization. The contract is for basic and applied research with two key objectives: (1) to test the hypothesis that variabilities in nanoparticle (NP) properties and tumor targets cause uncertainties in "FORMULA", and (2) to develop computational models to predict the...
The U.S. Food and Drug Administration (FDA) awarded a $901,888.19 definitive contract to the National Academy of Sciences (NAS), a non-profit organization, to produce a consensus report that identifies innovative technologies to advance pharmaceutical manufacturing. The contract, which is not set aside, was awarded on July 19, 2019 with a completion date of March 31, 2022. The report will assist the FDA's Center for Drug Evaluation and Research (CDER) in fostering the adoption of innovative...
The Food and Drug Administration (FDA) awarded a $248,553.46 firm fixed price contract to the Institute For Clinical Pharmacodynamics, Inc., a for-profit organization, to develop modernized susceptibility guidance for the antibiotic nitrofurantoin using a dynamic urinary tract in vitro infection model and pharmacometric approaches. This contract was awarded under the FDA's Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. The BAA...
The Department of Health and Human Services Food and Drug Administration (HHS FDA) awarded a $994,647.76 Purchase Order contract to Diant Pharma Inc. for a Pilot-Scale Nanoparticle Continuous Manufacturing System. Performance will take place in Storrs, Connecticut under firm fixed pricing terms. The contract begins on May 17, 2022 and concludes on November 29, 2023. Diant Pharma Inc. will provide pilot-scale continuous manufacturing equipment and services for developing nanoparticle drug...
This federal contract award, valued at $80,608.00, was issued by the Food and Drug Administration (FDA) to the National Council for Prescription Drug Programs, Inc. (NCPDP), a non-profit healthcare standards development organization. The contract is a firm fixed-price purchase order that seeks to improve the completeness and accuracy of the FDA's inventory of pharmacies that may be subject to regulation. The contract deliverables include obtaining data on pharmacy facility locations,...
This federal contract award to The Trustees of Princeton University, valued at $2,692,771.30, is for an Integrated Platform for Continuous RNA Nanoparticle Formulation and Drying. The award was made by the Food and Drug Administration (FDA) and is not associated with a set-aside program. The contract supports research and development to advance regulatory science in areas of interest to the FDA, as outlined in a Broad Agency Announcement (BAA) solicitation. Key subcontractors include Seran...
This federal contract award, with a ceiling value of $1,927,163.66, was issued by the National Institute on Drug Abuse (NIDA), a component of the U.S. Department of Health and Human Services. The contract was awarded to SRI International, a non-profit research and development organization, and is part of NIDA's Pharmacology and Toxicology for Neurotherapeutics Program (PTNP). The contract, which is a Delivery Order under the PTNP Indefinite Delivery Vehicle (IDV), is for IND-enabling studies....
This federal contract award, valued at $200,532.62, was issued by the National Institute on Drug Abuse (NIDA), a civilian agency within the National Institutes of Health (NIH), to Polypeptide Laboratories San Diego, LLC, a for-profit biotechnology and pharmaceutical research company. The contract is for the synthesis and distribution of opioid and related peptides, which supports critical biomedical research initiatives. This award is associated with a larger $2,781,317 Indefinite Delivery...