Federal Register notice: FDA makes available a draft guidance entitled Conducting Remote Regulatory Assessments Questions and Answers.
Federal Register notice: FDA issues an order debarring Kenneth Zipperer for five years from importing or offering for import any drug based on his con...
Federal Register proposed rule: FDA proposes to amend its regulations to move to a new format for National Drug Codes.
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FDA posts a draft guidance entitled Real-Time Oncology Review (RTOR) that discusses the program and its promotion of earlier submission of topline res...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...
