FDA issued guidance to interpret the terms used in the definition of suspect product set forth in section 581(21) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(21), and the definition of illegitimate product set forth in section 581(8)...
FDA released draft guidance for industry use of electronic systems, electronic records, and electronic signatures in clinical investigations of medical products, foods, tobacco products, and new animal drugs. The guidance provides recommendations regarding the...
March 2023, FDA released draft guidance to provide sponsors recommendations that assist in the development of monoclonal antibodies (mAbs) and other therapeutic proteins that directly target viral proteins or host cell proteins mediating pathogenic mechanisms of...
FDA released new guidance considerations for the design and conduct of externally controlled trials for Drug and Biological products. This industry guidance provides recommendations to sponsors and investigators considering the use of externally controlled clinical...
FDA published new draft guidance for M13A Bioequivalence (BE) for Immediate-Release (IR) Solid Oral Dosage Forms. The guidelines provide recommendations for conducting BE studies during development and post-approval phases for orally administered IR solid oral dosage...
