Federal Register notice: FDA extends the comment period for a 10/13 notice announcing a public meeting and requesting comments on a potential revised ...
Federal Register notice: FDA makes available a final guidance for industry #242 entitled In-Use Stability Studies and Associated Labeling Statements f...
FDA makes available a draft guidance on Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, a...
FDA Review posts the Federal Register notices for the week ending 11/27/2020.
Federal Register notice: FDA posts a final guidance on its drug development tool qualification process.
Federal Register notice: FDA makes available a final guidance entitled Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA...
FDA updates a CDRH Covid-19 guidance on notifying the agency of medical device discontinuance or shortages.