Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
October 19, 2009
April 24, 2020
40f1843c-d877-44dc-814b-63c7e743d168
Related Documents
Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for Treatment
Guidance DocumentOctober 5, 2012Center for Drug Evaluation and Research
Irritable Bowel Syndrome -- Clinical Evaluation of Products for Treatment
Guidance DocumentJune 14, 2012Center for Drug Evaluation and Research
Guidance for Industry Acute Bacterial Sinusitis: Developing Drugs for Treatment
Guidance DocumentOctober 4, 2012Center 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