Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
November 1, 1995
May 6, 2020
ecc5878c-4062-49df-90cc-6ac91b3adb4c
Related Documents
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
Guidance DocumentJuly 1, 1996Center for Drug Evaluation and Research
Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry
Guidance DocumentNovember 1, 1994Center for Drug Evaluation and Research
Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs) (PDF)
Guidance DocumentMarch 1, 2002Center for Biologics 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