The Quality Lowdown: Pandemic Site Evaluation Creativity On Display As COVID Clampdown Returns
With a virtual visit to SciVac in Israel, a belated Revance site inspection in California and two weeks at a Dr. Reddy’s site in India, the US FDA finds ways to overcome travel restrictions in its efforts to oversee drug manufacturing quality.
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Keeping Track: Opdivo Extends Label Into Neoadjuvant Lung Cancer; Acadia, Revance Resubmit
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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.