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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.

SK Life Sciences Seizure Drug Approved

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FDA approves a SK Life Science NDA for Xcopri (cenobamate tablets) for treating partial-onset seizures in adults.

Panel Summary on Amalgam, Other Metal Devices

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FDA posts a summary of the deliberations during an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee mee...

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...

HHS Publishes Fall 2019 Agency Rule List

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HHS publishes the latest unified rule agenda including 85 FDA items.

Draft Guide on Transdermal/Topical Drug Delivery

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Federal Register notice: FDA makes available a draft guidance entitled Transdermal and Topical Delivery Systems Product Developme...