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  • 1.  The regulatory headlines you need to know from October

    Posted 29-Oct-2021 13:02
    Here's a new feature we're trying over at Regulatory Focus: The monthly roundup!

    Here are six news stories from Regulatory Focus, the flagship online publication of the Regulatory Affairs Professionals Society, that regulatory affairs professionals absolutely have to know this month:

    IVDR: Commission proposes to delay implementation amid 'grave' notified body shortage

    FDA warns companies for GMP violations, conducting trial without IND

    ICH announces sign-off on good clinical practices guideline

    FDA withdraws more than 200 ANDAs over unsubmitted annual reports

    FDA draft guidance outlines criteria for conducting benefit/risk assessments

    FDA finalizes long delayed de novo classification rule


    Any stories you think belong in here? Let me know!

    We also run our monthly roundup on Instagram, in case you prefer to swipe through your headlines there.

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    Kari Oakes
    Rockville MD
    United States
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  • 2.  RE: The regulatory headlines you need to know from October

    Posted 30-Oct-2021 08:45
    Nice idea.  Keep it up.

    All the best,

    Bob

    Robert Schiff, PhD, RAC, CQA, FRAPS
    President and CEO
    Schiff & Company, Inc.
    583 Mountain Avenue
    North Caldwell, NJ 07006

    Tel  973-568-3361
    www.SchiffandCompany.com

    Celebrating 39 Years (1982-2021) of service in Compliance, Regulatory Affairs and Clinical Research



    Original Message


  • 3.  RE: The regulatory headlines you need to know from October

    Posted 31-Oct-2021 12:09
    Good idea, thanks.
     
     
     
    Frank Pokrop
    Director, Regulatory Affairs
    9975 Summers Ridge Road
    San Diego, CA 92121, US
    O:  858-302-0477
    C:   442-273-4827
     
     
    Quidel Confidentiality Notice: This electronic mail message, including any attachments, may contain information that is privileged, confidential, proprietary in nature, or otherwise private information that is protected by law from disclosure or subject to copyright and is intended only for the designated recipient. If you are not the designated recipient, you are hereby notified that any use, disclosure, distribution, reproduction, review, or copying is unauthorized and may be unlawful. If you have received this electronic message in error, please notify the sender immediately and delete the message completely from your computer system. Thank you.



    Original Message


  • 4.  RE: The regulatory headlines you need to know from October

    Posted 01-Nov-2021 13:10
    Thanks very much! 


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    Kari Oakes
    Rockville MD
    United States
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    Original Message


  • 5.  RE: The regulatory headlines you need to know from October

    Posted 01-Nov-2021 13:11
    Thank you!

    ------------------------------
    Kari Oakes
    Rockville MD
    United States
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    Original Message


  • 6.  RE: The regulatory headlines you need to know from October

    Posted 01-Nov-2021 13:10
    Thanks so much, Bob, and will do!

    ------------------------------
    Kari Oakes
    Rockville MD
    United States
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    Original Message


  • 7.  RE: The regulatory headlines you need to know from October

    Posted 31-Oct-2021 00:52
    Thank you for sharing.

    ------------------------------
    [Monaz] [Mysorewala] [M.Sc., DABT, ERT]
    [Manager]
    [SPARCL]
    [Vadodara] [Gujarat]
    [India][monazmysorewala@outlook.com][+91 9979118085]
    ------------------------------

    Original Message


  • 8.  RE: The regulatory headlines you need to know from October

    Posted 01-Nov-2021 13:11
    Thanks for taking the time to comment!

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    Kari Oakes
    Rockville MD
    United States
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    Original Message


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