FDA posts a draft guidance entitled Real-Time Oncology Review (RTOR) that discusses the program and its promotion of earlier submission of topline res...
FDA accepts for priority review a Daiichi Sankyo and AstraZeneca supplemental BLA for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating adult pat...
FDA releases a draft guidance on the expanded use of remote regulatory assessments beyond the Covid-19 pandemic to assess an FDA-regulated establishme...
Federal Register notice: FDA withdraws approval of three NDAs from multiple holders because they repeatedly failed to file required annual reports.
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Federal Register notice: FDA makes available a draft guidance entitled Real-Time Oncology Review (RTOR) that provides recommendations on the process f...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.