Considerations for Rescinding Breakthrough Therapy Designation
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
June 24, 2022
June 24, 2022
adc0ae37-722c-4b21-90ea-5a2087f771f0
Related Documents
Drug Master Files Guidance for Industry
Guidance DocumentNovember 15, 2019Center for Drug Evaluation and Research
Accelerated Approval – Expedited Program for Serious Conditions
Guidance DocumentDecember 5, 2024Center for Drug Evaluation and Research
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers
Guidance DocumentNovember 1, 2022Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox