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Section 351 of the Public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic ...
20 paź 1999 · The Food and Drug Administration (FDA) is amending the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Service Act (the PHS Act). In lieu of filing an establishment license application (ELA) and...
An application submitted under section 351(a) of the PHS Act is a “stand-alone” application that must contain all information and data necessary to demonstrate that the proposed product is...
Learning Objectives. What standard does FDA use to approve a Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act (PHSA)? What goes in a BLA? What is FDA’s process for reviewing a BLA? Agenda. Approval standard. Content and Organization of a BLA. FDA Review. FDA’s Decision.
Guidance for Industry. Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act. DRAFT GUIDANCE. This guidance document is being distributed for comment...
Section 351 of the Public Health Service Act (P.L 78-410) requires a manufacturer of biological products to first obtain a license to ship the product (vaccine) in interstate and/or foreign commerce or to import the vaccine into the United States.
(1) Biologics license applications under section 351 of the Public Health Service Act not permitted to incorporate by reference drug substance, drug substance intermediate, or drug product information contained in a master file.
