Product: Drugs Recipient: Recipient Name John T Rozkiewicz, Owner Recipient Title Dustin LeBleau, Owner Innovative Formulations, LLC dba Insane Labz 675 E Highway 43Harrison, AR 72601United […]

When searching for AMR-related device approvals it is helpful to know the associated Product Code for the class of AMR-related devices. Recently cleared IVD devices, including […]

Image Español People are seeking treatments to smooth smile lines and crow’s feet and plump up their lips, cheeks, and hands.  Injecting dermal fillers into the face […]

Do you feel depressed? Do not feel ashamed or alone. Women are more likely than men to feel depressed, although it is a major problem for […]

5017.8 Office of Pharmaceutical Quality Responsibilities for the Assessment of In Vitro Testing for Oral Drug Products Administered Via Enteral Feeding Tube Regulatory Review and Scientific […]

What is crowdsourcing? Crowdsourcing is the practice of asking the public for ideas, information, and opinions to help solve a problem in an innovative way or […]

In 2023 generic drugs continued to play a critical role in the U.S. health care system allowing patients greater access to needed medicines. Generic drugs are […]

Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent […]

Committee’s Official Designation Gastrointestinal Drugs Advisory Committee Authority The Gastrointestinal Drugs Advisory Committee (the Committee ) is established under 15 U.S.C. 1451 et seq.; 21 U.S.C. […]