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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 cited Novartis’ Vaccines and Diagnostics facility in Liverpool, UK, for lapses in its equipment cleaning and validation processes and inadequate investigations and CAPAs in a Form 483 issued June 11. Read More
A Texas drug compounder is recalling all lots of its sterile drug products after an FDA inspection found it had not investigated failed sterility tests. Read More
An Alabama compounder is recalling all of its nonexpired drug products over possible contamination issues and stopped production of sterile compounds after the FDA received reports of adverse events. Read More
The FDA Wednesday placed another Indian active pharmaceutical ingredient maker on its import alert list, adding one of Megafine Pharma sites to 46 other India-based finished drug and API sites whose products are banned from entering the U.S. 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 issued eight warning letters to active pharmaceutical ingredient manufacturers during fiscal year 2015 — all of them to non-U.S. companies, and all for data integrity issues. Read More
The FDA is trying to reassure drug companies by making it clear that the agency won’t use its quality metrics collection to spur 483s, warning letters and other enforcement actions. Read More