Questions and Answers on Current Good Manufacturing Practices for Drugs
As part of the Current Good Manufacturing Practices (CGMP) initiative announced in August of 2002, and to help FDA be…
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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…
Wuhu Nuowei Chemistry Co., Ltd. – 697727 – 02/04/2025
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
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
Postmortem Redistribution of Oxycodone
ABSTRACT The abuse of oxycodone (OC) as a “recreational” drug has increased in the last two decades the risk of…