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FDA Grants Alcobra Fast Track for Metadoxine

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FDA grants Alcobra Ltd. fast track status metadoxine extended release for treating Fragile X Syndrome.

FDA Evaluating Tramadol-related Breathing Adverse Event

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FDA says it is investigating the pain drug tramadol and its use in children aged 17 years and younger because of a report of slowe...

Panel to Discuss Vaccines for Pregnant Women

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Federal Register Notice: FDAs Vaccines and Related Biological Products Advisory Committee will meet 11/13 to discuss vaccines admi...

Selectors Sought for Patient Engagement Panel

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Federal Register Notice: FDA seeks participants for selecting consumer representatives for the Patient Engagement Advisory Committ...

FDA Breakthrough Not Really a Breakthrough: JAMA Authors

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Carnegie Mellon researchers say FDAs use of the term breakthrough when discussing the approval of new drugs could be misleading to...

FDA Priority Review for Amgen sNDA for Kyprolis

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FDA accepts for priority review an Amgen supplemental NDA for Kyprolis (carfilzomib) for injection for patients with relapsed mult...

Ex-Merck General Counsel Kuhlik Joins FDA

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Former Merck general counsel Bruce Kuhlik joins FDA as senior advisor to the commissioner.

FDA Accepts BLA for Primary Immunodeficiency Therapy

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FDA accepts for review an ADMA Biologics BLA for RI-002, and investigational therapy for treating primary immunodeficiency patient...

FDA Sets Up Device Patient Engagement Committee

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Federal Register Notice: FDA establishes the Patient Engagement Advisory Committee to provide advice to the commissioner on issues...

FDA Posts Product-Specific BE Recommendations

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Federal Register Notice: FDA makes available additional draft and revised draft product-specific bioequivalence recommendations.