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FDA Cites Documentation Lapses at Maiva Pharma

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FDA investigators cite manufacturing and documentation issues at an Indian sterile drug facility operated by Maiva Pharma Private ...

Public Trusts FDA Career Scientists Over Agency Leadership

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A new national survey sees Americans expressing significantly greater confidence in FDA career scientists than in the leaders who ...

FDA Biologics Chief Vinay Prasad to Step Down in April

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HHS says CBER director Vinay Prasad will step down at the end of April.

FDA Official Criticizes Advisory Committee Experts

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An FDA official discussing an ongoing dispute with UniQure raises concerns with outside experts who sit on agency advisory committ...

FDA Flags Expanded Recall of Reprocessed Cardiac Catheters

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FDA says an expanded recall by Medline Industries involving certain reprocessed electrophysiology and ultrasound catheters has bee...

Guidance Urges Comprehensive Responses to Inspection Findings

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FDA issues a draft guidance outlining how drug manufacturers should respond to inspection findings documented in an FDA Form 483, ...

FDA Operations Chief Announces Retirement

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FDA deputy commissioner for operations and chief operating officer Barclay Butler announces his retirement in the coming months.

Attorneys Review FDAs New Inspection Approach for Devices

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Ropes & Gray attorneys Joshua Oyster and Austin Laroche review in a WestLaw Today article FDAs new inspection approach for medical...

Regulate Outsourcing Ophthalmic Bevacizumab Products: Petition

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A Buchanan petition asks FDA to take administrative and enforcement action against 503B outsourcing facilities that are marketing ...

Senate Committee Has More Drug Supply Questions

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Bipartisan leaders of the Senate Select Committee on Aging ask CVS, Walgreens, and Walmart for additional information on their eff...