>>14488705 LB

>>14488501 LB

repost for more eyes

“The BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.”

"On March 23, 2020, the BPCI Act requires that an approved marketing application for a “biological product” under section 505 of the FD&C Act shall be deemed to be a license for the biological product (i.e., an approved BLA) under section 351 of the PHS Act."

LOOK SAUCE:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reference-product-exclusivity-biological-products-filed-under-section-351a-phs-act

https://www.fda.gov/drugs/guidance-compliance-regulatory-information/deemed-be-license-provision-bpci-act

>>14489598

https://qanon.pub

try searching for it, not exactly sure what is searched when using that feature, I've had issues in past with it. good luck

>>14489714

no images on Mac, those digits confirmed I need to sleep on the workaround. ty anon g'night fam.

May God continue providing all patriots and our families his cloak of protection and a calming spirit Amen

stay level headed and sharp you fine souls!