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« Back to: US Regulatory References

Historical Dates

  • 1902Biologics Control Act
    • As a result of the St. Louis tetanus outbreak and similar (but smaller) occurrences of contaminated smallpox vaccine and diphtheria antitoxin
    • Began federal regulation of biologics: Viruses, serums, toxins, analogous products
    • License of manufacturing establishments, inspection authority, sale Board within Treasury Dept to promulgate regulations, establish and maintain standards for safety, purity, potency
  • 1906Pure Food and Drug Act
    • Outlawed misbranded, adulterated foods and drugs
    • Provisions for seizures and criminal prosecution
  • 1937 – Division of Biologics Control (within NIH)
  • 1938Federal Food, Drug, and Cosmetic Act
    • Included biologics
    • This Act, however, did not modify or supersede the provisions of the 1902 Biologics Control Act. After 1938, the appropriate provisions of both Acts were used to regulate biologics.
  • 1944Public Health Service Act
    • Licensing controls for biologics separate from pre-marketing controls for drugs
    • Control over product as well as the establishment; the ELA and PLA
    • The 1902 Biologics Control Act was incorporated into Section 351
  • 1953 — James Watson (American) and Francis Crick (British) determined the structure of DNA
  • 1970s — PHS Act expanded to include blood, blood components, allergenic extracts
  • 1972 — Biologics regulations came under FDA – the Bureau of Biologics (BoB)
  • 1976 — Began implementing device regulations
  • 1981There were 108 reported cases of AIDS in the United States.
  • 1982 — BoB and Bureau of Drugs merged to form National Center for Drugs and Biologics (NCDB)
  • 1983Orphan Drug Act
  • 1983 — The biologics component of NCDB became the Office of Biologics Research and Review (OBRR) within the Center for Drugs and Biologics (CDB).
  • 1984 – HIV identified as the cause of AIDS
  • 1984 — Scientists identified and isolated the gene—the part of human DNA—that contains the instructions for production of Factor VIII.
    • Recombinant Factor VIII was first introduced in 1992.
  • 1987 – CDB split into CBER and CDER, Treatment IND regulations 
  • 1988 – CDB was divided into two new Centers, CBER and the Center for Drug Evaluation and Research (CDER).
  • 1990Safe Medical Devices Act
  • 1992 – PDUFA I, Accelerated Approval (Prescription Drug User Fee Act)
  • 1996 – Elimination of ELA for Specified Products, (ultimately for all biologics) exemptions from lot release for certain biological products
    • Upon approval, manufacturers of these products would receive a single biologics license instead of product and establishment licenses (21 CFR 601.2(c)).
  • 1997 – FDAMA (Food and Drug Administration Modernization Act) Introduction of BLA, amended PHS Act, 42 U.S.C 262(a), section 351(a) 
  • 1997PDUFA II 
    • expanded the goals to include activities related to the investigational phases of a new drug's development and it also added the goal of increasing FDA communications with industry and consumer groups.
  • 2002Bioterrorism Act 107-188
  • 2002PDUFA III : Enhancements to FDA review process
  • 2003 — Transfer of therapeutic biologics from CBER to CDER
  • 2007PDUFA IV