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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...
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...
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 DRAFT GUIDANCE.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...
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...
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.
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.
To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing addresses in § 600.2(a) or (b) of this chapter), on forms ...
