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FDA revised draft: Demonstrating Substantial Evidence of Effectiveness (FDA-2019-D-4964)

  • 1.  FDA revised draft: Demonstrating Substantial Evidence of Effectiveness (FDA-2019-D-4964)

    Posted 10 days ago

    Dear AAPS Pharmaceutical Quality team,

    AAPS is considering a response to the FDA revised draft: Demonstrating Substantial Evidence of Effectiveness (FDA-2019-D-4964).

    Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products

    From my review, this guidance would not impact PQ as it is more relevant to clinical development and regulatory. However I wanted to ask the group whether:

    1. Does this impact the PQ community and do we feel AAPS should respond? Yes/No

    2. If yes, who from the PQ team would volunteer their expertise to represent PQ on the Response Team?

    Please let me know by EOB July 8.

    Thank you,

    Joe



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    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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