Apr 20 2022 Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. In other words, these...

Apr 14 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic...

Apr 08 2022 Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2 This table includes information about authorized SARS-CoV-2...

Apr 06 2022 On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis...

Apr 05 2022 Update [4/5/2022] Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion...

Apr 04 2022 On April 19, 2022, the United States Food and Drug Administration(FDA) will provide a virtual MDUFA V public meeting that is...

Mar 29 2022 Cosmetic products (such as soaps, lotions, face and eye make up, fragrances, etc.) can provoke allergic reactions in some...

Mar 28 2022 The U.S. Food and Drug Administration(FDA) issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding...

Mar 25 2022 FDA Issues Additional Procedural Notice on Consumer Research on “Healthy” Symbol. The U.S. Food and Drug Administration is...

Mar 25 2022 FDA is reminding companies that manufactured alcohol-based hand sanitizers consistent with FDA’s temporary policies (guidance...

Mar 24 2022 On March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced...

Mar 23 2022 The U.S. Food and Drug Administration cautions that you should avoid skin creams, beauty and antiseptic soaps, and lotions...

Mar 21 2022 On February 23, 2022, the FDA issued a proposed rule to amend the device current good manufacturing practice (CGMP)...

Mar 17 2022 FDA requires a generic drug company to produce enough data to demonstrate the company can make a drug that can be...

Mar 14 2022 On March 14, 2022, FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022. OTC...

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...