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The U.S. House of Representatives late Monday approved a bill that would compensate patients for participating in clinical studies of rare diseases, sending it to President Barack Obama’s desk to be signed. Read More
Democrats on the House Oversight and Government Reform Committee are demanding answers on Valeant Pharmaceuticals’ massive price increases on two heart disease drugs. Read More
In an effort to boost the integrity of the drug supply chain, the FDA has issued a final rule authorizing it to destroy drug imports valued at $2,500 or less that have been refused admission into the country. Read More
An interim report shows that, since 2013, the FDA has conducted nearly 90 meetings with more than 50 drug companies interested in producing biosimilar products — at a cost of $65.9 million. 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
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