Showing items tagged as draft guidance

  • Surviving ISO 9001: 2015

    4 November, 2014 Christopher Paris, VP Operations, Oxebridge Quality Resources

    The next revision of ISO 9001 is due in 2015, and the standard is being anticipated with more controversy than any previous edition. The document, now in its Draft International Standard (DIS) stage, is nearly a done deal, with very few changes likely before it progresses to its final release.

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  • FDA Issues New Draft Documents Related to Compounding of Human Drugs

    23 February, 2015 MasterControl

    The U.S. Food and Drug Administration has issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.

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  • The Drug Supply Chain Security Act: Current Impact

    9 December, 2015 David Dills, Sr. Consultant, Regulatory & Compliance, Devices NovusLife

    On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law, bringing a successful conclusion to efforts by the industry and consumer groups to create a national pharmaceutical serialization and track and trace regulation, one that eliminated the patchwork of state laws in addition to providing new regulations for compounding pharmacies. This is the most complex pharma track and trace law ever passed.

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  • UDI: When the Rule is Not Enough

    30 August, 2016 MasterControl

    With less than two months to go before the UDI compliance date for Class II devices, on July 26, 2016, FDA issued a draft guidance related to what would seem to be the most basic of concepts: the form and content of the UDI. More specifically, the draft guidance states that its intent is to “clarify” for industry and FDA-accredited issuing agencies the form and content of the UDI, and to “better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with” the UDI rule.

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