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Laws, Regulations, and Recommendations Defined

Laws:

  • Written and approved laws are also known as statutes or acts. 
  • Statutory Law: A written piece of legislation; a law passed by a legislative body.  
  • Act: A bill which has passed through the various legislative steps required for it and which has become law.

Regulations:

The compilation of all regulations and rules promulgated during the previous year by the the United States government, combined with all the previously issued regulations and rules that are still in effect.

  • Federal Register and CFR
  • Agency rules announced in the Federal Register and codified in 21 of the Code of Federal Regulations (CFR)

Recommendations:

  • Guidance documents, Information sheets, and memorandums

FDA’s Legal Authority

Biological products are approved for marketing under provisions of the Public Health Service Act (PHS Act), and as amended by FDAMA, Section 123. However, because most biological products also meet the definition of “drugs” under the Federal Food, Drug, and Cosmetic Act (FD&C Act), they are also subject to regulation under FD&C Act provisions.

  1. BLA Approval Process (FDAMA)
  2. The Secretary shall approve a biologics license application:
    On the basis of a demonstration that
    • it is safe, pure and potent
    • the facility(ies) meet standards designed to assure that it continues to be safe, pure, and potent
    • If the applicant consents to the inspection of the facility(ies)