Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Eli Lillys Tauvid (flortaucipir F18).
Federal Register notice: FDA makes available a draft guidance entitled Real-Time Oncology Review (RTOR) that provides recommendations on the process f...
CDER director Patrizia Cavazzoni tells Friends of Cancer Research that the potential use of circulating tumor DNA as an endpoint to support an acceler...
FDA releases a final guidance entitled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.
FDA posts a final guidance entitled Orange Book Questions and Answers that answers commonly asked questions it has received from interested parties.
FDA posts an updated final guidance entitled on the unique device identification compliance date for class i and unclassified devices that extends the...
Faced with running out of 10-digit codes, FDA proposes to move to a 12-digit format for national drug codes.
Three Syneos Health executives give FDA six ways to strengthen its guidances on clinical trial diversity.