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Guide on Uncertainty with Benefit-Risk Device Decisions

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Federal Register notice: FDA releases final guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determinations i...

Multiple Issues Seen in Polimeros y Servicios Inspection

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FDA warns Costa Ricas Polimeros y Servicios about CGMP and other violations in its manufacturing of OTC drugs.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Balamurali K. Ambati, Haw Par Healthcare, Metuchen Pharmaceuticals,...

Pharma Most Poorly Regarded Industry: Gallup

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An annual Gallup Work and Education poll shows the pharmaceutical industry is the most poorly regarded industry by Americans, fall...

Consent Decree with Two Tennessee Companies

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FDA says a Tennessee federal judge entered a consent decree against two companies to prohibit them from distributing drugs, dietar...

FDA Warns Umbilical Cord Blood Firm

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FDA warns Stemell about multiple violations in its production of umbilical cord and umbilical cord blood products.

Review Period Determined for Bevyxxa

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Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Millennium Pharmaceuticals ...

CDERs Temple Covers Individualization in Drug Development

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CDER deputy center director for clinical science Robert Temple discusses the move by industry and the agency to the third age of d...

Comments Extension for MRI-safe Device Guide

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Federal Register notice: FDA extends the comment period for an 8/2 notice on a draft guidance on testing and labeling medical devi...

CGMP Deviations at Chinas Yino, Inc.

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FDA warns Chinas Yino, Inc., about significant CGMP deviations in its manufacturing of APIs.