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Biologic License Application (BLA) Checklist Under the Public Health Services Act, the Federal Food and Drug Administration (FDA) has been given the authority, concurrent with its authority under.

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A Biologics License Application, or BLA, is FDA's standard “full approval” mechanism for biological products, including therapeutics and vaccines.

A biologics license application (BLA) is a request to distribute a biologic across states. It generally is submitted after an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) and after the appropriate studies have been conducted.

Biologic License Application (BLA) Examples of biological products that would be subject to BLAs include monoclonal antibodies for in vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, therapeutic proteins, and non-vaccine immunotherapies.

Like an NDA, a BLA should include all information about the biological product that was gained over the development process and should demonstrate the biologic's safety, purity, and potency.

A Biologics License Application, or BLA, is FDA's standard “full approval” mechanism for biological products, including therapeutics and vaccines.

Biologics License Applications (BLA) Process (CBER)

A BLA is submitted by an applicant (manufacturer) and must contain data derived from non-clinical laboratory and clinical studies which, demonstrate that the manufactured product meets prescribed requirements of safety, purity, and potency (21 CFR Part 601.2).

FDA Review If it is complete, the review team has 6 to 10 months to make a decision on whether to approve the drug. The process includes the following: Each member of the review team conducts a full review of his or her section of the application.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232