DAILY REMINDER!!! pic.twitter.com/ZesUyxY52G— il Donaldo Trumpo (@PapiTrumpo) December 23, 2021
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce...
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.
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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 company seeking a BLA for its product must demonstrate that the product is “safe, pure, and potent,” which generally means completing robust, well-controlled clinical trials.
A company receiving a BLA for their product can introduce the product into interstate commerce and market it for its approved uses. A BLA also has no defined end date — assuming no significant problems emerge, the product can stay on the market indefinitely.
By contrast, an Emergency Use Authorization, or EUA, is just that — an authorization to distribute an otherwise unapproved product (or an approved product for an unapproved use) during an emergency formally declared by the Secretary of Health & Human Services. Both the substantive and procedural rules surrounding an EUA differ from those surrounding a BLA (or the BLA counterpart for small-molecule drugs, a New Drug Application or NDA).
Substantively, the standard for granting an EUA is whether, “based on the totality of scientific evidence available,” “it is reasonable to believe that the product may be effective” and that the “known and potential benefits… outweigh the known and potential risks.” Procedurally, an EUA lasts only as long as the underlying emergency. Further, the FDA may “revise or revoke” an EUA if the substantive evidence for granting it no longer exists.
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