U.S. Food and Drug Administration
Protecting and Promoting Your Health
Immediately necessary for an otherwise stalled drug development program to proceed. Type A meetings may include:
- Dispute resolution meetings as described in the Code of Federal Regulations (CFR), and in the Guidance for Industry Formal Dispute Resolution: Appeals Above the Division Level
- Meetings to discuss clinical holds in which development is stalled and a new path forward should be discussed
- Special protocol assessment meetings that are requested by sponsors or applicants after receipt of FDA evaluation of protocols under the special protocol assessment procedures
- Post-action meetings requested by the sponsor within 3 months after an FDA regulatory action other than an approval
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