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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
President Barack Obama on Sept. 15 nominated Robert Califf as the next FDA commissioner, capping a swift rise for the respected clinical researcher, who assumed the agency’s number two role — deputy commissioner for tobacco and medical products — in March. Read More
CDER Director Janet Woodcock came under fire Sept. 17 from senators demanding to know why the FDA is years behind Europe and Canada in establishing a workable program for biosimilars. Read More
Legislation to avoid a federal government shutdown cleared an important procedural hurdle in the Senate on Monday, as lawmakers voted 77 to 19 to end debate on a stopgap funding bill to extend current spending levels until Dec. 11. Read More
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