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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
The FDA has approved Impax’s generic versions of Valeant’s Mestinon Timespan tablets and Testred capsules, the first two products approved at the company’s Hayward, Calif., manufacturing plant following resolution of a 2011 warning letter. Read More
The two frontrunners for the Democratic presidential nomination, Hillary Clinton and Sen. Bernie Sanders of Vermont, released prescription drug policy proposals Sept. 22 that would cut prices and end pay-for-delay deals. Read More
Drugmakers are challenging the legality of FDA final guidance, calling for the design of generic tablets and capsules to be similar in size and shape to the reference drug to ensure patient acceptance. 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