Federal Register notice: FDA posts a list of five information collections that have been approved by the Office of Management and Budget.
FDA warns NeuroHydrate that it is marketing an unapproved new drug.
FDA and Bayer post their latest Essure adverse event reports.
FDA lifts a clinical hold on Regeneron and its odronextamab monotherapy trials in patients with follicular lymphoma and diffuse large B-cell lymphoma.
FDA describes the interim communications process it will use for issues it finds when reviewing records or other information requested in lieu or in a...
FDA acting commissioner Janet Woodcock tells the Food and Drug Law Institutes annual meeting that the agency is at a critical inflection point in the ...
FDA posts a revised guidance entitled Manufacturing, Supply Chain, and Drug and Biological Product Inspections During Covid-19 Public Health Emergency...
Two FDA officials update stakeholders online about agency efforts to improve its stakeholder and outside expert interactions to advance regulatory sci...