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Ex-FDAer Sherman Joins Aptinyx Board

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Former FDA principal deputy commissioner Rachel Sherman joins Aptinyxs board of directors.

Pediatric Labeling Changes for Sovaldi and Harvoni

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FDA summarizes labeling changes to Gileads Solvadi and Harvoni to add pediatric dosage forms.

FDA Warnings Yield Lower Chantix Use: Study

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Researchers say early FDA drug safety communications on Pfizers Chantix led to reduced prescribing in the VA health system, leadin...

Study Finds Better Adverse Events Filed by Consumers

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An new study suggests that FDAs 2013 move to a consumer-friendly adverse event reporting form has contributed positively to both t...

Info Collection Extension for ANADAs

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Federal Register notice: FDA submits to OMB an information collection extension for Abbreviated New Animal Drug Applications.

FDA Required Post-Market Studies Empty Threat: Professor

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Canadian health professor Matthew Herder says FDAs power to withdraw a drug if its manufacturer fails to produce useful required p...

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...