Delivery Method: Return Receipt Requested Product: Drugs Recipient: Recipient Name Stephen S. Laddy Recipient Title Chief Executive Officer MasterPharm LLC 115-02 Liberty Avenue, Suite 200South Richmond […]

On This Page Date: May 10 – 11, 2023 Day1: Wed, May 10 1:00 PM – 4:45 PM ET Day2: Thu, May 11 1:00 PM – […]

Docket Number: FDA-2020-D-1106 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research FDA is issuing this guidance to […]

As part of the reauthorizations of the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Act (BsUFA III), the Food and Drug […]

Dr. Roach: Welcome to the CDER Small Business and Industry Assistance (SBIA) Chronicles Podcast Series. Today’s topic: The Role of PharmacoDynamic Biomarkers in Biosimilar Drug Development […]

On this page Podcast and newsletter Podcast   Transcript Dr. Jeffry Florian, PhD – Associate Director of the Division of Applied Regulatory ScienceOffice of Clinical Pharmacology, Office of […]

The Food and Drug Administration is advising consumers not to purchase or use NORF 20, a product promoted for weight loss. This product was identified during […]

The Food and Drug Administration is advising consumers not to purchase or use Tantra Jelly Herbal Jelly for Him, a product promoted and sold for sexual […]

[4-07-2023] The Food and Drug Administration is advising consumers not to purchase or use American Bangster Black Label Optimum Formula 4000, a product promoted and sold […]