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  • 1.  Need OTC drug consultant/firm

    Posted 15-Sep-2020 08:17
    Edited by Pamela Martin 15-Sep-2020 15:36
    Good Morning,

    I'm looking for recommendations for a firm or consultant that has experience in submitting OTC drugs to the US FDA. Thank you!

    ------------------------------
    Pam Martin, RAC, MSc
    Regulatory Affairs Project Manager
    KLS-Martin L.P.
    Jacksonville, FL
    USA
    ------------------------------


  • 2.  RE: Need OTC drug consultant/firm

    This message was posted by a user wishing to remain anonymous
    Posted 15-Sep-2020 15:25
    This message was posted by a user wishing to remain anonymous

    Pamela, 
     I think you may need to go through De Novo and provide clinical data.
    Thanks

    Daisy Ni
    Original Message


  • 3.  RE: Need OTC drug consultant/firm

    Posted 16-Sep-2020 08:29
    Hi Pam.

    If you are looking for just someone to do product listing or establishment registration or updating then there are several folks on here that I have worked with in the past.  If you are looking for an (A)NDA submission to either obtain approval for a scope change or a new indication or a new administrative order (remember starting next month the OTC regulatory update added to the CARES Act will take effect!) then you might need to use someone more familiar with the (A)NDA submission process.

    Let me know if I can provide some recommendations if it is the former.  If it is the latter, then you really want to make sure that you have found someone with the correct/proper prior experience.  As I have only worked in the monograph area of OTC I don't have a lot of contacts that I have worked with who I can competently suggest to you based on my personal experience.

    ------------------------------
    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
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    Original Message


  • 4.  RE: Need OTC drug consultant/firm

    Posted 16-Sep-2020 08:50
    Hi Victor,

    I have limited information from the client about the OTC product, but my assumption is this might be an (A)NDA submission rather than OTC monograph. Either way, I'm open to your recommendations if this ends up going the OTC monograph route.

    Thank you very much for the information!

    ------------------------------
    Pam Martin, RAC, MSc
    Regulatory Affairs Project Manager
    KLS-Martin L.P.
    Jacksonville, FL
    USA
    ------------------------------

    Original Message


  • 5.  RE: Need OTC drug consultant/firm

    Posted 16-Sep-2020 08:42
    Pam, 
    OTC reform under the CARES Act creates new rule making for OTC Drugs. Under the OTC monograph order request (OMOR) FDA will have a 45 calendar day review time and $500k price tag. These changes are due to start in FDA FY starting Oct 1. Enforcement discretion is huge right now since hand sanitizers, etc. are OTCs with filings growing exponentially under EUA so expect major changes coming for OTCs, but probably enforcement discretion from FDA as they try to manage the changes required.  Feel free to reach out privately or send more specific IFUS questions to the group.

    Joy Frestedt, PhD, CPI, RAC, FRAPS,FACRP
    President and CEP
    Frestedt, Inc.
    952-426-1747

    Sent from my iPhone


    Sent from my iPhone



    Original Message


  • 6.  RE: Need OTC drug consultant/firm

    Posted 16-Sep-2020 08:59
    Hi Joy,

    Thank you for the information. I work in medical devices so I wasn't aware of the reform to OTC drugs.

    ------------------------------
    Pam Martin, RAC, MSc
    Regulatory Affairs Project Manager
    KLS-Martin L.P.
    Jacksonville, FL
    USA
    ------------------------------

    Original Message


  • 7.  RE: Need OTC drug consultant/firm

    Posted 16-Sep-2020 09:16

    Yes, drug/device combination regulatory negotiations require specific skills in both drug and device regs. I predict the OTC reforms will help to drive more cGMP improvements for OTCs to align more closely with 21CFR210 (general drug cGMP) and 21CFR211 (cGMP for finished drug products). These specify the need for clear testing to support drug identity, quality, purity, strength and safety details. The rules for drugs are quite different than devices, but some similarities exist too. Let me know if I can help with more specific details. We do a lot of work in this area and the details will depend, in part on the interactions between the device and the drug as well as the chemistry and efficacy of the drug for specific claim substantiation support.

     

    Joy Frestedt, PhD, CPI, RAC, FRAPS, FACRP

    President and CEO

    Best of 2020  Minneapolis (Minneapolis Awards Program)

    2019 Company of the Year (PharmaTech Outlook)

    Frestedt Incorporated

    9445 Minnetonka Blvd

    St. Louis Park, MN 55426

    Office: 952-426-1747

    Fax: 952-426-1757

    Cell: 612-219-9982

    Email: jf@frestedt.com

    Web: www.frestedt.com

     

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    Original Message


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