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Sherman Moves Into Califfs Former Position

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FDA promotes associate deputy commissioner for medical products and tobacco Rachel Sherman to deputy commissioner for medical prod...

FDA Probe Leads to Charge Against Drug Importer

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After an FDA Office of Criminal Investigations probe, federal prosecutors charge a Hoover, AL man with receiving and reselling mis...

Sen. Cotton Introduces Generic Drug Priority Bill

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U.S. senator Tom Cotton (R-AK) introduces the Safely Advancing Valuable and Inexpensive New Generic Solutions Act, a bill that wou...

FDA Approves Janssens Stelara for Crohns

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FDA approves a Janssen Biotech BLA for Stelara (ustekinumab) for treating moderately to severely active Crohns disease in adults (...

Eisai Submits sNDA for Fycompa Monotherapy Use

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Eisai Inc. files a supplemental NDA for Fycompa (perampanel) seeking monotherapy use for treating partial-onset seizures with or w...

FDA Denies Abbott Petition Seeking Humira Biosimilar Block

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In approving an Amgen biosimilar for the first copy of Abbotts Humira (adalimumab) for multiple inflammatory diseases (see story),...

Rep. Fitzpatrick Seeks Hearing on FDA and Device Safety

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Rep. Mike Fitzpatrick (R-PA) asks the House Energy and Commerce Committee for a hearing to investigate FDAs failings over medical ...

Comments Extended on Advisory Committee Appearances Guide

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Federal Register Notice: FDA has extended the comment period until 11/26 for a guidance on Procedures for Evaluating Appearance Is...

Guidance on Generic Facility Self-Identification

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Federal Register Notice: FDA makes available a guidance on Self-Identification of Generic Drug Facilities, Sites, and Organization...

Wells Pharmacy Recalls Non-sterile Products

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Wells Pharmacy Network recalls all sterile human and veterinary products prepared since February due to an FDA concern over a lack...