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FDA, Others Warned on Finalizing Regs Before Trump in Office

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House Republican leaders write FDA commissioner Robert Califf and other federal agency heads to caution them against finalizing pe...

Draft FDA Software Guidance Raises Questions

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Two Morgan, Lewis attorneys outline questions and concerns raised by a recent FDA draft guidance on clinical evaluation of softwar...

Progress Seen in Pediatric Studies

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Experts surveyed to update a Tufts Center for the Study of Drug Development report on pediatric drug studies see efforts moving in...

CGMP Violations Found in Japans Sekisui Medical

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FDA warns Japans Sekisui Medical Co. about CGMP and data integrity issues in its manufacturing of active pharmaceutical ingredient...

FTC Enforcement Policy on OTC Homeopathic Drug Claims

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The Federal Trade Commission announces a new Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopath...

Patient Advocates Help Develop Rare Disease Products

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Contract research organization executives at Premier Research discuss ways in which patient advocates play a lead role with FDA an...

Device Recalls Up, Drugs Down: Stericycle

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Stericycles third quarter recall index shows an increase in medical device recalls and a decrease in pharmaceutical recalls.

Drug Warning Letters More than Doubled in 2016: Analysis

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An Unger Consulting analysis finds that the number of FDA GMP Warning Letters more than doubled from FY 2015 to FY 2016.

Doctors Favor Biologic Name Suffixes: Poll

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Doctors surveyed by the Biologics Prescribers Collaborative say they favor a meaningful four-letter suffix denoting the manufactur...

Bayers Essure Gets Boxed Warning, Patient Checklist

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FDA says that Bayers controversial Essure permanent birth control system has new labeling that includes a Boxed Warning and a Pati...