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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
Responding to more than a dozen Form 483 responses from compounders that say they’re not subject to FDA GMP requirements, the agency put compounders on notice outlining enforcement penalties and bulk substance rules that compounders must adhere to. Read More