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FDA Reopens Tobacco Product Comment Period

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Federal Register notice: FDA reopens for 20 days the comment period on a 9/25 proposed rule on premarket tobacco product applicati...

Intercept NDA for NASH Drug Accepted

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FDA accepts for priority review an Intercept Pharmaceuticals NDA for obeticholic acid seeking accelerated approval for treating fi...

Draft Guide on Certificates of Confidentiality

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Federal Register notice: FDA has made available a draft guidance entitled Certificates of Confidentiality; Guidance for Sponsors, ...

Info Collection on FOIA Identity Form

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Federal Register notice: FDA seeks comments on an information collection extension for Certification of Identity; Form FDA 3975.

Info Collection for Device Shortage Data System

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Federal Register notice: FDA sends to OMB an information collection for Medical Devices; Shortages Data Collection System.

Justice Hits Foundation Conspiracy with Drug Firms

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The U.S. Justice Department announces that a Florida foundation has agreed to pay $4 million to resolve allegations that it violat...

CBER Raps RichSource for Cell Therapy Claims

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CBER Office of Compliance and Biologics Quality issues RichSource Stem Cells an untitled letter over promotional statements on its...

Info Collection Revision on Biosimilar Program

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Federal Register notice: FDA seeks comments on an information collection extension for General Licensing Provisions; Section 351(k...

Endo BLA Accepted for Cellulite Therapy

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FDA accepts for review an Endo International BLA for collagenase clostridium histolyticum (CCH) for treating cellulite in the butt...

Trump Extends FDA, Other Funding for 30 Days

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President Trump signs a short-term continuing resolution that funds FDA and other agencies at FY 2019 funding rates through 12/20.