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Guide on Type A Medicated Articles

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Federal Register notice: FDA makes available a draft guide on demonstrating bioequivalence for soluble powder oral dosage form pro...

Clinical Decision Support Software Guide

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Federal Register notice: FDA makes available a draft guidance entitled Clinical Decision Support Software.

FDA Awards Contract to Advance Drug Safety System

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FDA awards a new five-year contract to enhance its Sentinel System and prepare it for managing real-world data to improve the safe...

Rituxan Approved for Granulomatosis in Children

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FDA approves Genentechs Rituxan (rituximab) injection to treat granulomatosis with polyangiitis and microscopic polyangiitis in ch...

Galt Marketing Email Gets FDA Warning

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An email distribution by Galt Pharmaceuticals to health professionals draws an FDA Warning Letter on insomnia drug Doral (quazepam...

Abbott Recharge-Free Neurostimulation Device OKd

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FDA approves Abbotts Proclaim XR recharge-free neurostimulation system for people with chronic pain.

Meeting on ICH Clinical Trial Guide

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Federal Register notice: FDA announces a 10/31 public meeting on an International Council on Harmonization guideline on clinical t...

Digital Health Innovation Guidances Out

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FDA issues new and updated guidances to clarify regulatory oversight of various digital health tools.

Zogenix Resubmits Dravet Syndrome NDA

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Zogenix resubmits an NDA for Fintepla (fenfluramine hydrochloride) for treating seizures associated with Dravet syndrome.

Draft Guide on Device e-Submissions

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Federal Register notice: FDA makes available a draft guidance on medical device regulatory electronic submissions.