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Amicus Plans NDA for Fabry Disease Drug

[ Price : $8.95]

Amicus Therapeutics says it plans to submit an NDA for migalastat for treating Fabry disease.

FDA Panel Backs Flu Vaccine for Elderly

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FDAs Vaccines and Related Biological Products Advisory Committee recommends accelerated approval for a NVS Influenza Vaccines BLA ...

FDA Approves Octapharma NDA for Nuwiq

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FDA approves an Octapharma NDA for Nuwiq (antihemophilic factor-recombinant), indicated for treating adults and children living wi...

Obama Nominates Califf as Next FDA Commissioner

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President Obama nominates FDA deputy commissioner for medical products and tobacco Robert M. Califf as the agencys next commission...

GPhA Controlled Correspondence Concerns

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The Generic Pharmaceutical Association says that an FDA draft guidance on controlled correspondence is counter to provisions in th...

MAPP on CDER Medical Policy Council

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CDER issues a MAPP on the organization and work of the Centers Medical Policy Council.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Coram Healthcare Corp. of Indiana dba Coram CVS/Specialty Infusion Services, Jay...

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...