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Info Collection on Biosimilar Formal Meetings

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Federal Register notice: FDA submits to OMB an information collection extension Guidance for Industry: Formal Meetings between the...

Ex-FDA Top Lawyer Returns to Sidley Austin

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Former FDA chief counsel Rebecca Wood rejoins Sidley Austin to co-lead both the firms food, drug and medical device regulatory pra...

Cook Medical Gets Warning Letter Close-out

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Cook Medical gets an FDA close-out letter resolving a 2014 Warning Letter for processes related to the companys quality system at ...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Lernapharm (Loris), Longood Medicine and two letters to Medtronic.

Revised Compounding MOU for States

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Federal Register notice: FDA makes available for public comment of a revised draft document entitled Memorandum of Understanding A...

Meeting on Drug Shortage Root Causes

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Federal Register notice: FDA announces a 11/27 public meeting entitled Identifying the Root Causes of Drug Shortages and Finding E...

Trump Admin Taps Inside Counsel as Top FDA Lawyer

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Trump Administration senior associate counsel to the president Stacy Cline Amin moves to FDA to serve as chief counsel.

FDA to Meet with Patients Advocating LASIK Ban

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After years of resistance, FDA agrees to meet this week with injured LASIK patients seeking a ban on the lasers used in the contro...

Panel to Review Shire Constipation NDA

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Federal Register notice: FDA announces a 10/18 Gastrointestinal Drugs Advisory Committee meeting to review a Shire NDA for a const...

Guide on Post-approval Drug Substance Changes

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FDA posts a draft guidance entitled Postapproval Changes to Drug Substances.