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The pure food and drug act
- 1906
- Federal Inspection for meat, plants
- paved way for more regulations
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The Food and Drug Administration
- FDA
- Federal agency under Health and Human Services
- Protect and promote public Health - Food, Drugs, Medical devices
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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
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USDA
- US Department of Argriculture
- APHIS (Animal and Plant Health Inspection Service)
- Protect US agriculture from pests and diseases
- Field tests of GE plants
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EPA
- Regulates pesticides and Herbicides
- Regulates plants engineered to produce pesticides
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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
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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)
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Phase I
- Safety
- 10-80 healthy volunteers
- any unexpected side effects?
- Dosage levels established
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Phase II
- Efficacy
- several dozen to hundred patients
- look for side effects
- look for any benefit to patient
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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
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Phase IV
- Post marketing surveillance trial
- thousands (or millions) of people take the drug; FDA still intersted in effects
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Food supplements
- are regulated by FDA as foods not drugs
- can not make drug claims but can make health claims
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GLP
Good Laboratory Practice
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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)
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GCP
Good clinical practice
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SOP
- Standard operating procedures
- Each procedure has a clearly described method for accomplishing it
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Once a page is completed
- full legal signature
- date 10 april 2010 or April 10, 2010 only
- witness signature and date
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