All FDA articles – Page 2

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    European Medicines Agency issues draft guidance on data integrity

    2016-08-31T10:45:00Z

    The European Medicines Agency and the Pharmaceutical Inspection Co-operation Scheme have released draft guidance for pharmas on how to maintain data integrity during testing, manufacturing, packaging, distributing, and monitoring of medicines. Jaclyn Jaeger reports.

  • Article

    Calls for More Data Sharing to Step Up Terrorism Fight

    2015-09-22T10:00:00Z

    Washington wants Corporate America to step up its attention to terrorism risk. That was the message at a recent congressional hearing, the latest instance of voices saying business and government should cooperate to uncover terrorists’ sophisticated financing schemes. “Most of the early warning signs reside with the private sector, and ...

  • Article

    Drug, Device Companies Face New FDA Electronic Submissions

    2015-06-30T09:45:00Z

    The Food and Drug Administration is overhauling how it accepts submissions for a host of filing requirements imposed on drug and medical device makers. For many, this will be the first time the submissions have ever been filed electronically. While the move away from paper documents may ultimately be advantageous ...

  • Article

    FTC, FDA Take Closer Look at Disclosures

    2015-01-21T12:00:00Z

    The Federal Trade Commission is cracking down on companies with questionable advertising disclosures. The Food and Drug Administration, meanwhile, may allow shorter lists of side effects in drug and medical device ads, even as it prepares tougher standards for how these companies use online advertising and social media. The focus ...