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. Form 356h specifies the requirements for a BLA. This includes:
A BLA is submitted after an investigational new drug has been approved. If the Form 356h is missing information, the FDA will reply within 74 days.[3] A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number.
After approval, annual reports, reports on adverse events, manufacturing changes, and labeling changes must be submitted.
^"Biologics License Applications (BLA) Process (CBER)". FDA. 2015. Retrieved July 9, 2016.
^(PDF). Food and Drug Administration. Archived from the original (PDF) on February 3, 2017. Retrieved January 27, 2017.{{cite web}}: CS1 maint: archived copy as title (link)
^Group, The FDA. "The Biologics License Application (BLA) Process Explained". www.thefdagroup.com.
February 25, 2024
biologics, license, application, biologics, license, application, defined, food, drug, administration, follows, biologics, license, application, request, permission, introduce, deliver, introduction, biologic, product, into, interstate, commerce, regulated, un. 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 Form 356h specifies the requirements for a BLA This includes Applicant information Product manufacturing information Pre clinical studies Clinical studies Labeling 1 Some biological products are regulated by the Center for Drug Evaluation and Research CDER while others are regulated by Center for Biologics Evaluation and Research CBER 2 A BLA is submitted after an investigational new drug has been approved If the Form 356h is missing information the FDA will reply within 74 days 3 A BLA asserts that the product is safe pure and potent the manufacturing facilities are inspectable and each package of the product bears the license number After approval annual reports reports on adverse events manufacturing changes and labeling changes must be submitted See also editNew drug application Investigational new drugReferences edit Biologics License Applications BLA Process CBER FDA 2015 Retrieved July 9 2016 Archived copy PDF Food and Drug Administration Archived from the original PDF on February 3 2017 Retrieved January 27 2017 a href Template Cite web html title Template Cite web cite web a CS1 maint archived copy as title link Group The FDA The Biologics License Application BLA Process Explained www thefdagroup com Retrieved from https en wikipedia org w index php title Biologics license application amp oldid 1189003880, wikipedia, wiki, book, books, library,
