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    PDA TR 20Sep20 uploaded

    By: A. Sabrina Restrepo , Merck & Co. Inc , 13 hours ago
    Posted in: Vaccines Control Strategy TR

    Document Name : PDA TR 20Sep20 Description Uploading version post-meeting that shows sections 4.1 - 4.3 complete except subsection 4.2.1. Pending input from Cristiana regarding lines 392, 393, 400 and 461. Sabrina ...

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    ASN-0005 Meeting Recording_ 2020-09-14

    By: Valeria Shirvani , PDA S&RA , 4 days ago
    Posted in: BSRPDA Standard 05-201x, Consensus Method for Rating 0.1 Mycoplasma Reduction Filters

    Please see the attached recording of the ASN-0005 Meeting on September 14, 2020. Kind regards, Valeria ------------------------------ Valeria M. Shirvani Research and Data Coordinator, Science and Regulatory Affairs Parenteral Drug Association® (PDA) ...

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    RE: PDA/FDA: Questions for panelists

    By: Josh Eaton , PDA S&RA , 5 days ago
    Posted in: ATMP Advisory Board

    Hi Miriam, There is no specific outline for the Ask the Regulators Panel as they are meant to be truly free-form for any question to be asked. There are however two focus tracks: one on reviews and one on inspections. The panel members are ...