Drugmakers Say FDA’s FAR Guidance Contradicts Existing Regulations

FDA guidance on submitting field alert reports contradicts federal regulations on the time frame for when reports must be submitted, Perrigo and GlaxoSmithKline said in public comments.

GSK said the July draft guidance conflicts with the Code of Federal Regulations on the definition of “day zero” — the day the clock starts on the three-day period drugmakers have to submit a report to the agency.

The draft puts day zero at the day the contract laboratory learns there’s a problem; existing regulations put day zero at the day the NDA or ANDA applicant learns there’s a problem. The draft guidance specifically notes that “the day a contract lab learns of a sterility failure is day 0, and you must submit the FAR by close of business on day 3,” GSK said, calling on the agency to amend this section to “the day a contract lab reports information to the application holder.”