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August 2, 2022
Guidance Document August 2022 This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt...
August 1, 2022
Guidance Document August 2022 The purpose of this guidance is to advise dietary supplement manufacturers, distributors, and other stakeholders of our intent to exercise enforcement discretion with...
July 29, 2022
Today, FDA is announcing the availability of a level 2 guidance for industry titled, Changes to Disposable Manufacturing Materials: Questions and Answers. FDA receives questions about the limited...
July 28, 2022
The Europe Introduction - EU Implementation Guide has been prepared by the European Medicines Agency (EMA) upon consultation with different stakeholders (representatives of marketing authorisation...
July 27, 2022
On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351), that is intended to...
July 27, 2022
Final Guidance July 2022 This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications...
July 27, 2022
Final Guidance July 2022 This guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy (commonly referred...
July 25, 2022
July 2022 As part of FDA’s continued efforts to improve transparency and provide helpful information to regulated industry and the public, the agency is issuing two final guidances for generic drug...
July 21, 2022
Draft Guidance July 2022 This guideline provides recommendation to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical...