- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Medical Products and Tobacco, Office of Special Medical Programs, Office of Combination ProductsOffice of Medical Products and Tobacco, Center for Drug Evaluation and ResearchOffice of Medical Products and Tobacco, Center for Devices and Radiological HealthOffice of Medical Products and Tobacco, Center for Biologics Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.” This guidance finalizes the draft guidance issued October 22, 2015, which provides recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use, packaged in multiple-dose, single-dose, and single-patient-use containers.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2015-D-3438.