FDA unveils a pilot program to evaluate model-informed drug development approaches that could improve clinical trial efficiency and increase the proba...
Federal Register notice: FDA makes available a guidance on Considerations for Design, Development, and Analytical Validation of Next Generation Sequen...
Federal Register notice: FDA makes available a final guidance entitled Use of Public Human Genetic Variant Databases to Support Clinical Validity for ...
FDA rescinds an Alkermes refuse-to-file letter issued late last month on its NDA for ALKS 5461 (buprenorphine and samidorphan), an investigational dru...
FDA Review posts the Federal Register notices for the week ending 4/13/2018.
FDA releases the FDA-483 detailing 12 observations from a 2017 inspection at Koreas Celltrion drug manufacturing facility.
FDA posts a guidance on Special Protocol Assessment that provides drug manufacturers with information about the procedures and policies adopted by CDE...
Federal Register notice: FDA announces a 5/1 Antimicrobial Drugs Advisory Committee meeting to discuss a Siga Technologies NDA for tecovirimat.