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Lima & Pergher Industria failed to provide stability data to ensure its drug products’ expiration dates and did not perform microbiological testing on each finished product, the FDA said in a warning letter to the Brazilian company. Read More
The cancer moonshot’s blue ribbon panel made 10 recommendations to the National Cancer Advisory Board to guide scientific direction for the national research initiative, specifically organizing an immunotherapy clinical trials network. Read More
An FDA inspection found microbiological contamination of drugs purporting to be sterile at a Bausch & Lomb manufacturing facility in Florida, according to a Form 483 handed to the company. Read More
The FDA has tentatively declared that vinpocetine does not classify as dietary ingredient, citing its clinical investigation as a new drug and composition as a synthetic compound. Read More
The FDA issued a 483 to Glades Drugs after an inspection revealed that three adverse event reports were associated with Vitamin D3 supplement capsules. Read More