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The FDA should establish searchable names and correct incomplete entries in its inactive ingredient database to enhance its accuracy and usability, generic drug and excipients makers say. Read More
Just days after the Trans-Pacific Partnership pact cut exclusivity protections for drugmakers outside the U.S., a proposal that would extend a waiver allowing poor countries to ignore drug patent laws is raising more ire. Read More
The FDA could issue guidance on demonstrating interchangeability between a biosimilar and its reference product by the end of the first quarter of next year. Read More
The FDA hit another Indian active pharmaceutical ingredients maker with a warning letter after an inspection revealed data integrity issues and significant cGMP violations. Read More
A federal appeals court has refused to rehear the biosimilars case pitting Sandoz against Amgen, letting stand a July decision allowing Sandoz to launch its Zarxio biosimilar of Amgen’s cancer therapy Neupogen (filgrastim) in September. Read More
The FDA has reopened the comment period for draft guidance on established conditions for reporting chemical, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More
Novartis has launched a program to provide 15 drugs in Kenya, Ethiopia and Vietnam, with plans to eventually expand to 30 low- and middle-income countries. Read More
The FDA is heeding industry requests to simplify the ANDA approval process by allowing generics makers to submit proposed labeling instead of final printed labeling. Read More
Sen. David Vitter is asking the FDA to process its current backlog of more than 3,000 generic drug applications, especially in light of recent prescription drug price increases. Read More