Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings : Draft Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
October 16, 2018
April 11, 2024
3c7d812a-8f9d-42ac-b54e-ad63ed389dab
Related Documents
Master Protocols for Drug and Biological Product Development
Guidance DocumentDecember 21, 2023Center for Drug Evaluation and Research
Labeling for Biosimilar and Interchangeable Biosimilar Products
Guidance DocumentSeptember 18, 2023Center for Drug Evaluation and Research
Clinical Lactation Studies: Considerations for Study Design
Guidance DocumentMay 9, 2019Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.