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The FDA is seeking feedback on a draft addendum to the International Conference on Harmonisation’s good clinical practice guideline aimed at streamlining approaches to trial design, conduct, oversight, recording and reporting. Read More
The U.S. Patent and Trademark Office has denied Celgene’s request to sanction a hedge fund owner for seeking to profit by challenging the validity of drug patents, saying there was nothing inherently wrong with the action. Read More
The FDA has issued final guidance for generics makers on making formal requests for information, including on topics that are still under agency consideration. Read More
PhRMA has named longtime medical device industry executive and healthcare advocate Stephen Ubl to be its next president and CEO, taking over for John Castellani, who is retiring at the end of the year. Read More
The FDA has revoked its March approval of Sun Pharma’s Elepsia XR antiseizure medication, citing manufacturing quality problems at the Halol, India, facility where the drug is produced. Read More
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