Benefit-Risk Assessment for New Drug and Biological Products
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
October 17, 2023
August 10, 2024
90bf84f4-05cf-4617-b13d-bbb345349aed
Related Documents
Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Guidance for Industry
Guidance DocumentJune 22, 2023Center for Drug Evaluation and Research
Identification of Medicinal Products — Implementation and Use
Guidance DocumentMarch 30, 2023Center for Drug Evaluation and Research
Q13 Continuous Manufacturing of Drug Substances and Drug Products: Guidance for Industry
Guidance DocumentMarch 1, 2023Center 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.