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Risk Communication Advisory Panel to Review Strategic Plan

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Federal Register Notice: FDAs Risk Communication Advisory Committee meets 11/ to discuss and make recommendations on the agencys d...

FDA Announce Naloxone Mobile App Competition

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Federal Register Notice: FDA announces the 2016 FDA Naloxone App Competition, a prize competition designed to help reduce deaths a...

Woodcock Wanted Drug Approved Before Review Completed: FDA Records

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A summary of an internal CDER dispute surrounding the approval of Sareptas controversial Duchenne drug Exondys 51 shows that Cente...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Option Care Enterprises, Jeffreys Drug Store, Sarkli/Repechage and ZO Skin Healt...

FDA Rescinds Teva SPA After Dosing Changed

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FDA rescinds a Teva Pharmaceutical Industries Special Protocol Assessment after two dosing options were discontinued in multiple s...

KemPharm Seeks Dispute Resolution of Pain Drug Denial

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KemPharm decides to file a formal dispute resolution challenge to an FDA rejection of its claim of abuse deterrence for the labeli...

FDA Approves Med-El PMA for Hearing Device

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FDA approves a Med-El USA PMA for the Synchrony EAS (Electric Acoustic Stimulation) Hearing Implant System.

FDA Contest for Developing Naloxone Mobile App

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FDA announces a Naloxone App Competition, a public contest focused on developing a mobile phone application that can connect opioi...

Comments Sought on Scheduling Changes for 12 Controlled Drugs

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Federal Register Notice: FDA seeks comments on abuse potential, actual abuse, medical usefulness, trafficking, and impact of contr...

Docket Created for Biomarkers Used in Novel Drug/Biologic Approvals

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Federal Register Notice: FDA creates a docket to receive suggestions, recommendations, and comments on a list of biomarkers that w...