Drug Quality Sampling and Testing Programs
FDA CDER’s quality sampling and testing programs assess pharmaceutical quality after drugs are on the market.
FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
On February 11, 2025, the Food and Drug Administration approved mirdametinib (Gomekli, SpringWorks Therapeutics, Inc.), a kinase inhibitor, for adult…
FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has…
Chengdu Innovation Pharmaceutical Co., Ltd. – 698786 – 02/05/2025
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
ISOThrive, Inc. – 688547 – 02/04/2025
Clinical Investigator
Strukmyer LLC dba Strukmyer Medical – 692686 – 01/30/2025
CGMP/Finished Pharmaceuticals/Adulterated
Wuhu Nuowei Chemistry Co., Ltd. – 697727 – 02/04/2025
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Postmortem Redistribution of Oxycodone
ABSTRACT The abuse of oxycodone (OC) as a “recreational” drug has increased in the last two decades the risk of…
Model-Informed Drug Development Paired Meeting Program
FDA is conducting a MIDD Pilot Program to facilitate the development and application of exposure-based, biological, and statistical models derived…
MIDD Paired Meeting Program Frequently Asked Questions
MIDD Pilot Program Frequently Asked Questions (FAQs)