Federal Register notice: FDA seeks comments on an information collection extension for Permanent Discontinuation or Interruption in Manufacturing of C...
FDA releases a draft guidance for industry entitled Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study ...
Fresenius Kabi USA initiates a mandatory field action software update for its Alyx Component Collection System because of an issue identified when the...
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 unveils a pilot program to evaluate model-informed drug development approaches that could improve clinical trial efficiency and increase the proba...
FDA Review posts the Federal Register notices for the week ending 4/13/2018.