The Regulatory Environment

  1. The pure food and drug act
    • 1906
    • Federal Inspection for meat, plants
    • paved way for more regulations
  2. The Food and Drug Administration
    • FDA
    • Federal agency under Health and Human Services
    • Protect and promote public Health - Food, Drugs, Medical devices
  3. Regulatory Agencies
    • USDA= plants . Plant pests, animal vaccines
    • EPA= Microbial/Plant pesticides , toxic substances, microorganisms , animals producing toxic substances
    • FDA= food, animal feeds, food additives, human vaccines, meical divices, transgenic animals
  4. USDA
    • US Department of Argriculture
    • APHIS (Animal and Plant Health Inspection Service)
    • Protect US agriculture from pests and diseases
    • Field tests of GE plants
  5. EPA
    • Regulates pesticides and Herbicides
    • Regulates plants engineered to produce pesticides
  6. FDA
    • Ensures that (food and Medicines) are safe and effective
    • Some things pose no foreseeable risk and are granted generally recognizs as safe (GRAS) status
    • _Genetically engineered chymosin for examp.
    • oversees the intro. of new drugs and its manufacturing
    • if a prod is found to be unsafe , its removed from market
  7. Drug Approval Process
    • R&D produces a new drur candidate
    • Investigational new drug application (IND)
    • Phase I Testing
    • Phase II Testing
    • Phase III Testing
    • NDA: New Drug Authorization (FDA approval)
  8. Phase I
    • Safety
    • 10-80 healthy volunteers
    • any unexpected side effects?
    • Dosage levels established
  9. Phase II
    • Efficacy
    • several dozen to hundred patients
    • look for side effects
    • look for any benefit to patient
  10. Phase III
    • Comparative benefit versus other treatment
    • Hundreds- thousands of patients
    • Double blind study best
    • testing can take years
    • Might compare to placebo ; more commonly compare to standard treatments
    • risk /benefit analysis
  11. Phase IV
    • Post marketing surveillance trial
    • thousands (or millions) of people take the drug; FDA still intersted in effects
  12. Food supplements
    • are regulated by FDA as foods not drugs
    • can not make drug claims but can make health claims
  13. GLP
    Good Laboratory Practice
  14. cGMP
    • current good manufacturing practice
    • repeatability(ensuring that things are done in the same manner each time)
    • traceability ( every reagent, material etc.. should be traceable if there is a problem the cause can be identified more easily)
    • documentation ( if it isnt documented it didn't happen)
  15. GCP
    Good clinical practice
  16. SOP
    • Standard operating procedures
    • Each procedure has a clearly described method for accomplishing it
  17. Once a page is completed
    • full legal signature
    • date 10 april 2010 or April 10, 2010 only
    • witness signature and date
Card Set
The Regulatory Environment