What The FDA’s Inspections Q&A Guidance Really Means: It’s Time To Offer Virtual Inspections
Compliance experts see possibilities in offering video tours as the FDA offers “holistic” approach to assessing sites during pandemic.
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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.
Keeping Track: Incomplete Responses For Unusual Times; Qtrypta Is Latest CRL
Highlights from complete response letter news from the Pink Sheet’s US FDA Performance Tracker.
Spike In Drug Recalls Expected As US FDA Resumes Inspections, Targeting COVID-19-Related Problems
Attorneys and recall consultants say any firm distributing products associated with COVID-19 should expect to receive the highest level of scrutiny as the US FDA resumes inspections and uses its enforcement muscle to prohibit companies from making adulterated products, such as hand sanitizers, or making fraudulent claims.