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Federal Register notice: FDA makes available a draft guidance entitled Transdermal and Topical Delivery Systems Product Developme...

New Info Collection on Cosmetic Events Survey

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Federal Register notice: FDA sends to OMB a proposed information collection on Web-Based Pilot Survey To Assess Allergy to Cosmeti...

Info Collection Extension for Dear Doctor Letters

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Federal Register notice: FDA sends to OMB an information collection extension for its Guidance for Industry on Dear Health Care Pr...

FDA-483 from 2 Aurobindo Unit Inspections

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FDA releases FDA-483s from inspections at two Aurobindo units in India.

New Calquence Indication Approved

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FDA works with Australia and Canada to approve a new indication for AstraZenecas Calquence.

WLF Wants Ban on Drug Prices in Ads

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Washington Legal Foundation says the DC Court of Appeals should uphold a decision barring HHS from requiring drug companies to inc...