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Sponsor Name and Address Changes

Sponsor Name and Address Changes. Jason Smith, D.C. Consumer Safety Officer. Sponsors should notify CVM of changes to their corporate identity and address. The notification from the sponsor should:.

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Sponsor Name and Address Changes

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  1. Sponsor Name and Address Changes Jason Smith, D.C. Consumer Safety Officer

  2. Sponsors should notify CVM of changes to their corporate identity and address.

  3. The notification from the sponsor should: • Include a Form FDA 356v if the change in corporate identity or address change affects an approved New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA) • Describe the specific change to the corporate name or address they are making • Specify the effective date of the change • Include the name, address, and phone number of an individual authorized to speak for and act on the behalf of the company

  4. Sponsor requirements continued 5. In the event that the new corporate identity does not have a drug labeler code, the sponsor will need to request a drug labeler code 6. Include a comprehensive list of all Investigational New Animal Drugs (INAD), Generic Investigational New Animal Drugs (JINAD), New Animal Drug Applications (NADA), Generic New Animal Drug Applications (ANADA), Veterinary Medical Files (VMF), General Correspondence files (G) etc.

  5. When the appropriate information has been submitted by the sponsor, CVM will then: • Send an acknowledgement letter • Prepare and publish a notice in the Federal Register documenting the change of corporate identity and or address • Publish revisions to section 510.600(c) or a specific approval regulation

  6. What to expect in the acknowledgement letter: • An acknowledgement of the change in name or address • A notification that we have prepared a Federal Register notice for publication and will make appropriate changes to regulations found in Part 510.600 of the CFR (if the transfer involves an approved application). • A statement reminding the sponsor that they are responsible for complying with all applicable laws and regulations governing new animal drugs.

  7. Questions? Contact info: Dave Newkirk, PhD, Deputy Office Director for Administration 240-276-8307 David.Newkirk@fda.hhs.gov Jason Smith, D.C. Consumer Safety Officer 240-276-9341 Jason.Smith@fda.hhs.gov

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