Sponsored Research Agreement (Pro-Supplier)

Draft an agreement with a research institution to perform clinical research on behalf of a manufacturer. This template includes helpful drafting notes and alternate clauses.

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• Institutional Review Board (IRB) Formation, Organization, and Operation Checklist
  Identify legal and compliance considerations related to the formation, organization, and operation of an IRB.

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• FDA Drug Regulatory Activity Tracker—stay informed on new developments.  

• Final Guidance. Announcement of the availability of a final guidance for industry entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” This guidance is intended to assist submitters by describing the electronic over-the-counter (OTC) monograph submissions requirement in the Federal Food, Drug, and Cosmetic Act and providing recommendations and other information on how to send such OTC monograph submissions to the FDA in electronic format.
• Draft Guidance. Announcement of the availability of a draft guidance for industry entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers.” This draft guidance provides answers to commonly asked questions from applicants and other interested parties regarding postapproval manufacturing changes made to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act.
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