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FDA Sends Info on Drug Supply Chain to OMB

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Federal Register Notice: FDA submits a proposed collection to the Office of Management and Budget on a guidance on Drug Supply Cha...

FDA to Destroy Certain Imported Drugs

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Federal Register Final rule: FDA implements its authority to destroy a drug valued at $2,500 or less that has been refused admissi...

FDA Accepts sNDA for Vandas Fanapt

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FDA accepts for review a Vanda Pharmaceuticals supplemental NDA for Fanapt (iloperidone) seeking approval as a maintenance treatme...

Medivators Recalls Hemocor High Performance Hemoconcentrator

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Medivators recalls its Hemocor High Performance Hemoconcentrator due to ultrafiltration performance concerns.

Final Rule on Destroying Drugs Refused Admission to U.S.

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FDA publishes a Federal Register final rule on Administrative Destruction of Certain Drugs Refused Admission to the United States....

GPhA Wants More Communication from Generic Drugs Staff

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The Generic Pharmaceutical Association says CDERs Office of Generic Drugs should provide more opportunities to communicate with OG...

FDA Approves Medtronic PMA for MRI-safe ICD

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FDA approves a Medtronic PMA for its Evera MRI SureScan ICD System, an implantable cardioverter defibrillator for use with magneti...

FDA Names New Directors for Foreign Posts

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FDA implements a a changing of the guard at its foreign offices and installs new directors at several of them, as well as headquar...

FDA Panel Backs Collegiums Long-acting Oxycodone

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An FDA advisory committee votes unanimously to recommend approval for Collegium Pharmaceuticals NDA for Xtampza ER (oxycodone exte...

FDA Sets Fees for Tropical Disease Priority Review

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Federal Register Notice: FDA announces the fiscal year 2016 fee rates for using a tropical disease priority review voucher.