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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
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
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
Two new studies point to concerns over the FDA’s increasing use of expedited development and approval pathways — programs that rely on early-stage trials that produce less robust data. Read More
A federal appeals court has affirmed Shire Pharmaceuticals’ patents for Vyvanse, blocking efforts by five drugmakers to market generic versions of the attention deficit hyperactivity disorder drug. Read More
An interim report shows that the FDA has conducted nearly 90 meetings with more than 50 drug companies interested in producing biosimilar products since 2013 at a cost of $65.9 million. Read More