Sasha
I adore all your analogies.
-Pizza/ Laundromat storefronts!!!
-Helicopters dropping $$ from the sky
-The ' " you buy a beer brand today, it isn't the same beer brand next day ( on good manufacturing practices/ lack thereof)
Etc..
Your analogies make this rather abstruse, complex contractual legal speak much more understandable an…
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes:
* Applicant information
* Product/Manufacturing information <--
* Pre-clinical studies
* Clinical studies
* Labeling <--
**
I covered this as well. The vials are labeled for a reason, and that's so that you can back-track if needed. These aren't price stickers at a grocery store, it's stuff that's going to be injected into someone, it has to be right!
Sasha
I adore all your analogies.
-Pizza/ Laundromat storefronts!!!
-Helicopters dropping $$ from the sky
-The ' " you buy a beer brand today, it isn't the same beer brand next day ( on good manufacturing practices/ lack thereof)
Etc..
Your analogies make this rather abstruse, complex contractual legal speak much more understandable and bearable!
Thanks! You Rock!
Also, very glad to see new people via the comments discovering you and Katherine's work!
Sasha nails it! The branding is critical, because it's part of the licensure.
You can't retroactively "approve" a product, that was produced outside of a cGMP environment. And there's good reason for that!
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber
**
The Biologics License Application (BLA) 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 <--
**
I covered this as well. The vials are labeled for a reason, and that's so that you can back-track if needed. These aren't price stickers at a grocery store, it's stuff that's going to be injected into someone, it has to be right!
http://winduprubberfinger.com/blog1.php/2021/11/30/comirnaty-vanishing-or-was-it