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A federal court has invalidated six key patents for Amarin’s potential blockbuster heart drug Vascepa, opening the door for generic competitors. Read More
The FDA issued a warning letter to an over-the-counter drug manufacturer in Hangzhou, China for serious GMP violations including inadequate testing for drug products prior to release. Read More
The FDA cited Anchen Pharmaceuticals for four violations at its manufacturing facility in Irvine, California, including particulate contamination. Read More
The FDA issued a warning letter to DermaPharm for serious GMP violations including inadequate testing of raw materials and finished products. Read More
Windlas Healthcare drew a warning letter from the FDA after agency investigators found serious data integrity violations at its API manufacturing facility in Uttarakhand, northern India. Read More
With the FDA’s foreign inspections on hold through April due to the coronavirus outbreak, the agency is doing “anything and everything” to make use of international regulators to keep inspections going, according to a senior CDER official. Read More
An Indian drug manufacturer’s facility in Salcete, Goa drew a warning letter from the FDA for serious violations, including inadequate cleaning that left drug product residues inside manufacturing equipment. Read More