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CDER Seeking Input on Study Data Template

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Federal Register notice: CDER seeks comments on a proposed Analysis Data Reviewers Guide (ADRG) template that was developed under ...

Ad Group Refers Synergy Claims to FTC

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The Better Business Bureaus National Advertising Division says Synergy Pharmaceuticals declined to participate in a self-regulator...

Drug Companies Greater Use of Real-World Evidence: Report

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A Tufts Center for the Study of Drug Development company survey finds that use of real-world evidence is increasing and will grow ...

Device Recalls Down, Drug Recalls Up in 3rd Quarter

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Stericycles third quarter 2017 recall index says medical device recalls fell, while drug recalls increased.

Guide on Recurrent Herpes Labialis Drug Development

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Federal Register notice: FDA makes available a guidance on Recurrent Herpes Labialis (RHL): Developing Drugs for Treatment and Pre...

Proposed Info Collection on Target Product Profile Guide

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Federal Register notice: FDA submits to OMB a new proposed information collection supporting its Draft Guidance for Industry and R...

Comments Sought on Info Collection for Expedited Product Programs

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Federal Register notice: FDA seeks comments on an information collection revision for its Guidance for Industry on Expedited Progr...

Adverse Reports from United Pharmacy Injectable

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FDA says it has investigated two adverse event results from a United Pharmacy compounded glutamine, arginine, and carnitine produc...

FDA OKs Expanded Abuse Deterrent Claims for Xtampza

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FDA approves a Collegium Pharmaceutical supplemental NDA to enhance the label for Xtampza ER (oxycodone extended-release), an abus...

Courts Should Defer to FDA Pediatric Policy: Professor

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A Yale Law School professor says court should back FDAs denial of pediatric exclusivity for Amgens Sensipar because one of the com...