Biologics license application
License
📊 Rating
1 news mentions · 👍 0 likes · 👎 0 dislikes
📌 Topics
- Healthcare Regulation (1)
- Biotechnology (1)
- Public Health (1)
🏷️ Keywords
Moderna (1) · FDA (1) · Flu vaccine (1) · mRNA technology (1) · Biologics License Application (1) · Regulatory approval (1) · Pharmaceuticals (1)
📖 Key Information
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows:
The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards.
📰 Related News (1)
-
🇬🇧 FDA declines to review Moderna application for new flu vaccine
<p>Moderna requests meeting to discuss refusal as decision could have implications for all new and updated vaccines</p><p>US regulators will not revie...
🔗 Entity Intersection Graph
People and organizations frequently mentioned alongside Biologics license application:
- 🌐 Regulation (1 shared articles)
- 🏢 Moderna (1 shared articles)
- 🌐 Influenza vaccine (1 shared articles)
- 🏢 Food and Drug Administration (1 shared articles)