Federal Register notice: FDA modifies the organizational structure of the Office of Regulatory Affairs and field offices.
FDA publishes a guidance explaining the scope of its oversight of clinical decision support software in light of changes mandated by the 21st Century ...
FDA warns Chinas Zhejiang Tianyu Pharmaceutical Co. about CGMP deviations in the production of active pharmaceutical ingredients.
Federal Register notice: CBERs Office of Tissues and Advanced Therapies has modified its organizational structures to redesignate it a super office t...
CDER Office of Clinical Pharmacology researchers outline the value of leveraging clinical pharmacology principles during drug development and evaluati...
Rep. A Donald McEachin introduces legislation to allow generic drug manufacturers to independently add safety-related information to product labels.
FDA researchers say the use of pediatric extrapolation since 2015 has expanded and been refined.
House and Senate negotiators agree to terms to reauthorize the agencys user fee programs under a clean absent any policy/program riders measure that...
