Just-released FDA enforcement statistics shows that recalls in FY 2016 fell 10% compared with recalls tracked in 2015.
A CDER Quarterly Update shares the latest information on Center involvement in biomarker development.
Federal Register Notice: FDA releases a revised draft guidance on bioequivalence recommendations for generic difluprednate emulsion.
Reuters says some drug company executives are wary of efforts to rollback FDA regulations and speed drug approvals.
Pediatric cancer advocate Richard Plotkin explains why legislation to allow terminally ill patients to try experimental drugs without FDA involvement ...
A Health Affairs blog post raises concerns about provisions in the 21st Century Cures Act that can change FDA approval standards for drugs and medica...
The CDER Exclusivity Board defines the scope of Daiichi Sankyos three-year exclusivity for its MorphaBond extended-release morphine product.
FDA exempts Evoke Pharma from having to perform a human factors validation study requirement prior to submitting an NDA on its late stage product Gimo...