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Workshop on Gonorrhea Drug Development

[ Price : $8.95]

Federal Register notice: FDA, the National Institute of Allergy and Infectious Diseases, and the Centers for Disease Control and P...

Info Collection on Drug GMP Dispute Resolution

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Federal Register notice: FDA sends to OMB an information collection extension entitled Formal Dispute Resolution: Scientific and T...

CGMP Deviations at Proquimes SA Productos Quimicos Especializados

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FDA warns Colombias Proquimes SA Productos Quimicos Especializados about CGMP deviations in its production of APIs.

FDA Touts U.S.-Canada RCC Achievements

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FDAs Global Engagements Team reviews 10 years of successes under the U.S.-Canada Regulatory Cooperation Council.

Add All Lorcaserin Drugs to List of Drugs Not to Compound: Public Citizen

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Public Citizen says FDA should adopt a policy that whenever it announces that a drug has been withdrawn for reasons of safety or e...

Braintree Wants Restrictions on Tablet Colonoscopy Prep

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Braintree asks FDA to require particular specifications for any colonoscopy preparation tablet citing its Sutab as the reference-l...

5th Circuit Backs FTC in Impax Reverse Payment Case

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The 5th Circuit Court of Appeals says FTC acted correctly in issuing a cease-and-desist order to Impax preventing any future rever...

Warning Sent to Maison Terre After Infant Death

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FDA sends a Warning Letter to Maison Terre after conducting testing on its drug product labeled as Goldenseal Root Powder Organic ...

Senate Approves FDA Active Moiety Definition

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Attorney Andrew Goldfarb says Senate passage of a bill to codify in law FDAs active moiety definition for Waxman-Hatch five-year n...

Medtronic Thoracic Stent Class 1 Recall

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FDA classifies as Class 1 a Medtronic recall of all unused Valiant Navion thoracic stent grafts due to stent fractures and endolea...