Federal Register notice: FDA makes available a final guidance entitled Unique Device Identification: Policy Regarding Compliance Dates for Class I and...
Baxter Healthcare recalls (Class 1) its Abacus software application due to a risk that final printed bag labels for compounded mixtures may contain in...
FDA accepts for review a Sandoz BLA for what the company describes as the first biosimilar copy of Biogens Tysabri (natalizumab), indicated for treati...
FDA posts a draft guidance entitled Real-Time Oncology Review (RTOR) that discusses the program and its promotion of earlier submission of topline res...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FDA releases a draft guidance on the expanded use of remote regulatory assessments beyond the Covid-19 pandemic to assess an FDA-regulated establishme...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).