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    Manufacturer Page Rewritten - HTM

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    The Manufacturers Assistance Branch of the FDA can answer questions on policy, procedures, clinical investigations, adverse event reporting, application submissions, and IND applications. They provide assistance to both large and small manufacturers as well as trade associations. Contact can be made via phone at 800-835-4709 or 301-827-1800 or by email at MATT@CBER.FDA.GOV. The branch provides training and answers questions.

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    Manufacturer Page Rewritten - HTM

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    The Manufacturers Assistance Branch of the FDA can answer questions on policy, procedures, clinical investigations, adverse event reporting, application submissions, and IND applications. They provide assistance to both large and small manufacturers as well as trade associations. Contact can be made via phone at 800-835-4709 or 301-827-1800 or by email at MATT@CBER.FDA.GOV. The branch provides training and answers questions.

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    The Manufacturers Assistance Branch of the FDA can answer questions on policy, procedures, clinical investigations, adverse event reporting, application submissions, and IND applications. They provide assistance to both large and small manufacturers as well as trade associations. Contact can be made via phone at 800-835-4709 or 301-827-1800 or by email at MATT@CBER.FDA.GOV. The branch provides training and answers questions.

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    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pdf or txt
    9 views1 page

    Manufacturer Page Rewritten - HTM

    Uploaded by

    api-894731
    The Manufacturers Assistance Branch of the FDA can answer questions on policy, procedures, clinical investigations, adverse event reporting, application submissions, and IND applications. They provide assistance to both large and small manufacturers as well as trade associations. Contact can be made via phone at 800-835-4709 or 301-827-1800 or by email at MATT@CBER.FDA.GOV. The branch provides training and answers questions.

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    U.S. Food & Drug Administration Search

    FDA Homepage Food Drugs Medical Devices Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Combination Products
    1 This is a rewrite of the text on the Industry page: http://www.fda.gov/cber/
    manufacturer.htm.
    Biologics, Blood & Vaccines
    The Industry page refers to both the “Manufacturers Assistance Branch” and the
    “Manufacturers Assistance and Technical Training Branch”. I didn’t know which name
    Biologics, Blood & Vaccines was current, so I used the shorter of the two in this wireframe.
    Biologics, Blood &
    Vaccines The page now has an announcement for a training program that closed on February 21.
    Guidance, I did not include this announcement in this wireframe.
    Guidance, Compliance & Regulatory Information
    Compliance &
    The Manufacturers Assistance Branch can answer questions on many policy and Email Page
    Regulatory procedural topics including: 2 These are the same general phone numbers shown in the Contact Us module. Are there
    Information o Information on clinical investigators Print Page more specific numbers to use?
    1
    o How to report an adverse event
    Bookmark and share
    Acts, Rules & o How to submit an application online (electronic submission) Is the e-mail address an individual’s name or an acronym for the Manufacturers
    Regulations o How to submit an Investigational New Drug Application (IND) to administer Get email updates Assistance and Technical Training Branch? If the latter, can it be in all CAPS, so it will
    an investigational product to humans
    Subscribe to RSS look more like an acronym?
    Guidances Please contact us:
    o Phone: 800-835-4709 or 301-827-1800 2
    Establishment o E-mail: matt@cber.fda.gov
    Registration
    We answer questions and provide training to:
    o Large and small manufacturers
    Compliance Activities o Trade associations

    Enforcement
    Acts, Rules & Regulations Contact Us
    Post-Market Activities Public Health Service Act 800-835-4709
    301-827-1800
    Rules
    Imports & Exports
    Comprehensive List of Laws Enforced octma@cber.fda.gov

    Code of Federal Regulations – Biologics Enforced Center for Biologics


    Evaluation and Research
    1401 Rockville Pike, Suite
    Guidances & SOPs 200N
    Rockville, MD 20852-1448
    Guidances by Topic & Year
    Resources for You Manual of SOPs Media Inquiries

    Consumers & Healthcare About CBER


    Providers Imports & Exports
    Compliance Program Guidance Manual – Imported CBER-Regulated
    Industry
    Products
    Export Certificates
    Importing Samples for Research Use Only

    Other Topics
    Compliance Activities
    Enforcement
    Post-Market Activities

    Page Last Reviewed:


    Page Last Updated:
    Content Source:

    Project: FDA Template Wireframes


    FDA Footer Prepared By: Cari A. Wolfson, Focus on U!
    Date Modified: 10/28/2008 by Design for
    Context
    Guidance List Page - CWp22 Page Number: 1 of 1

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