Product Title and Initial US Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
January 19, 2018
April 14, 2020
e7792ae4-c049-4de1-bf07-f0bf1ff29121
Related Documents
Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for Industry
Guidance DocumentFebruary 3, 2022Center for Drug Evaluation and Research
Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry
Guidance DocumentJuly 6, 2018Center for Drug Evaluation and Research
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format
Guidance DocumentJanuary 12, 2023Center 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