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A Pharmacia & Upjohn plant was slammed with its second FDA Form 483 in five years for GMP deficiencies ranging from quality systems, facilities and equipment to materials, production and laboratory systems. Read More
The FDA has tapped private industry to find a permanent director for the Office of Pharmaceutical Quality, naming Michael Kopcha of Novartis Consumer Health to the role. Read More
The International Conference on Harmonisation has issued first-ever quantitative guidance on the evaluation and control of mutagenic impurities in medicines to limit potential cancer risk. Read More
Sun Pharma is recalling more than 216,000 bottles of felodipine blood pressure tablets and the antidepressant imipramine because the varnish on labels is leaching a chemical into the containers. The news comes on the heels of a July recall of bupropion hydrochloride tablets made at Sun’s Halol, Gujarat, India, plant. Read More
In preparation for a September 2017 expiration, the FDA has scheduled a Dec. 18 public meeting to kick off reauthorizing the Biosimilar User Fee Act. Read More
Starting Oct. 1, pharma companies seeking to cash in on a rare pediatric disease priority review voucher must pay the FDA $2.727 million — $165,000 more than in the fiscal year ending Wednesday. Read More
Manufacturers of highly soluble immediate-release tablets and capsules may use standard release tests instead of method development and specification-setting exercises to show how quickly the drug dissolves, the FDA says in draft guidance. Read More
Seattle Genetics received a six-observation Form 483 from the FDA for documentation and adverse event reporting failures related to its only approved product — cancer drug Adcetris. Read More