Biologics License Applications; Procedures & Requirements
OMB 0910-0338
The Public Health Service Act and FDA regulations require manufacturers to submit a license application for review and approval prior to marketing a biological product in interstate commerce. In addition, applicants must submit to FDA advertising and promotional labeling. Manufacturers or applicants or are also required to submit changes, including labeling, changes to an approved application, as well as advertising and promotional labeling changes. The information submitted to FDA in a biologics license application, supplement to an approved application, or other similar submission is used to determine if a product is safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use. The regulations also describe the types of postmarketing studies (PMS) that require status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. FDA uses the information submitted from PMS reports to meet its reporting obligations under section 506B of the Food Drug & Cosmetic Act and section 130(b) of the Food and Drug Administration Modernization Act.
The latest form for Biologics License Applications; Procedures & Requirements expires 2023-02-28 and can be found here.
Biologics; Licensing; General Biological Products Standards; and Additional Standards Biologics; Licensing; General Biological Products Standards; and Additional Standards
Federal Enterprise Architecture: Health - Consumer Health and Safety
| Form Form FDA 2252 | TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE | Fillable Fileable | Form |
| Form | www.fda.gov/media/70712/download | Other | |
| Form FDA 356h | Application to Market a New or Abbreviated New Drug or Biologic For Human Use | Fillable Fileable | Form |
| Form Form FDA 2252 | TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE | Fillable Fileable | Form and instruction |
| Form Form FDA 2253 | TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE | Fillable Fileable | Form and instruction |
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