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 16 2022 The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go...

Mar 15 2022 On March 15 2022, The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol...

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...