Three Hyman, Phelps attorneys say one good thing to come out of the pandemic could be FDA adoption of principles of fairness in an executive order and...
Federal Register notice: FDA issues an order debarring Keith Komar for five years from importing or offering for import any drug into the U.S.
FDA issues a draft guidance on how to use and submit forms FDA 3988 and 3989 for certain postmarketing studies or clinical trials.
Three FDAers explain how the Oncology Center of Excellence has worked with clinical trial sponsors to find ways to safely continue cancer trials durin...
California names a Scientific Safety Review Workgroup charged with independently evaluating any Covid-19 vaccine approved by FDA before it can be used...
FDA accepts an sNDA for AstraZenecas Tagrisso cancer drug and will give it priority review.
FDA clears an Ezra 510(k) for its artificial intelligence and its use in assisting radiologists in their analysis of prostate MRI scans.
FDAs Medical Device Development Tools program lists an agency-qualified tool that medical device sponsors can use in developing and evaluating medical...