We want to give you some advice on Pre-Submission which leads to successful FDA approval. FDA offers a Pre-submission program and...

Mar 08 2022 March 01 2022, the U.S. Food and Drug Administration issued three final guidances to industry regarding cancer clinical...

Mar 07 2022 FDA I Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research A rare disease is any disease that...

Mar 07 2022 Date: March 29, 2022 Time: 2:00 PM - 3:00 PM ET ABOUT THIS WEBINAR During this webinar, FDA will provide an overview of the...

Mar 03 2022 We provide safety and regulatory information about soaps and lotions. Lotions, soaps, and other cleansers may be regulated as...

Mar 02 2022 The Food and Drug Administration (FDA) warns cosmetics companies when they make claims about their products that classify...

Mar 01 2022 FDA has granted accelerated approval for Vonjo (pacritinib) capsules to treat adults who have a rare form of a bone marrow...

Feb 28 2022 [2/25/2022] The U.S. Food and Drug Administration is continually monitoring how authorized and approved treatments for...

Feb 28 2022 [2/24/2022] The U.S. Food and Drug Administration has revised the emergency use authorization for Evusheld (tixagevimab...

Feb 24 2022 Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death...