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Medivators Recalls Hemocor High Performance Hemoconcentrator

[ Price : $8.95]

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

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

FDA Issues EUA for Ebola Diagnostic

[ Price : $8.95]

Federal Register Notice: FDA issues an Emergency Use Authorization for a in vitro diagnostic for detecting the Ebola Zaire virus.

Guidance on Provisional Tobacco Product Enforcement

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Federal Register Notice: FDA releases a guidance: Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not...

Panel to Discuss Organon NDA

[ Price : $8.95]

Federal Register Notice: FDAs Anesthetic and Analgesic Drug Products Advisory Committee will meet 11/6 to discuss an Organon USA N...