Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry

Issue Date: January 19, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling
Status: Draft

Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry

This guidance is intended to assist applicants in complying with certain labeling requirements for human prescription drug and biological products (21 CFR 201.56 and 201.57).

Download the Guidance Document