Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products
Update on New Guideline; by USFDA Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format…
Pharmaceutical Guideline1 min read
Update on New Guideline; by USFDA
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format
Guidance for Industry
This guidance provides recommendations for developing the content and format of a patient Instructions for Use (IFU) document for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA).
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Combination Products (OCP)
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
July 2022
Labeling
Get new articles
Practical GMP, QA and regulatory guidance for students and professionals, plus pharma job openings as they are posted. Free, about one email a week.
Related reading
21 CFRCode of Federal Regulations, CFR
The list of titles of the Code of Federal Regulations The 21 CFR is the Title 21 for Food and Drugs
GeneralMultiple Endpoints in Clinical Trials Guidance for Industry
GUIDANCE DOCUMENT Multiple Endpoints in Clinical Trials Guidance for Industry OCTOBER 2022 Docket Number: FDA-2016-D-4460 Issued by: Center for Biologics…
GeneralPurified Water Monograph
Purified Water Note—For microbiological guidance, see USP general information chapter Water for Pharmaceutical Purposes 1231. H2O 18.02 DEFINITION