Program Participants Urge The FDA To Adopt Some Pharmaceutical Quality Metrics And Avoid Others
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”
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US FDA GMP Warnings To OTC Firms In China, South Korea
Cosmo Bio's response to remote records request shows the South Korea company was marketing an unapproved OTC acne treatment without adequate release or stability testing. In China, Hubei Kangzheng was manufacturing an ophthalmic in a Grade D area without appropriate microbial controls.
The Quality Lowdown: More Inspection Delays, More Findings On Sterility And Investigations
US FDA hits firms in New Jersey, South Korea and China with warning letters. Meanwhile, Catalent and several outsourcing facilities work on Form 483 inspection findings as Mylan, Viona and Lohxa announce drug recalls.
Public-Private Consortium To Strengthen Essential Medicines Supply Under White House Initiative
President Biden’s 100-day plan relies on Defense Production Act authorities to increase resilience of critical domestic pharmaceutical supplies.