Drug development Flashcards
Pure Food and Drug Act
caused by
Requires what
caused by addiction to opium and cocaine
Requires labeling patent medicines
Modified Food, Drug and Cosmetic Act
Caused by
Requires what
caused by diethyleneglycol (anitfreeze) tragedy
Required safety
Durham-Humphrey Amendment
Caused by
Requires
caused by many new drugs, prescription and OTC
Required - prescription drugs, labeled as more addictive, more toxic and serious
Kefauver-Harris Amendment
Caused by
Requires what
caused by Thalidomide, which causes phocomelia
Requires safety and efficacy
Dietary supplement health and education act
Caused by
Requires
Regulates herbal products
Requires herbal products to be defined as foods
Distinction between prescription and OTC drugs
Addiction/abuse liability
Relative safety
Intent of use - does it require professional input/control
What all does FDA regulate
Foods, dietary supplements, bottled water, food additives, drugs, biologics, medical devices, cosmetics, veterinary products, tobacco products, advertising of these
Phases of Drug testing
Animal preclinical testing
Phase I, II, III
Marketing (phase IV)
Phase I of drug testing
small group of healthy subjects to test safety, doses, administration and other kinetics
Phase II of drug testing
small group of subjects with condition to bet treated to test safety and efficacy
Phase III of drug testing
Extended clinical phase, large group of subjects, using double blind construct, placebos and multi-sites group to test for statistical efficacy
Marketing (phase 4)
see how the product does in production
IRB
NDA
IND
Institutional review board
New drug application
Investigational new drug
Orphan Drug Act
for rare disease to encourage drug development
Fast track
shorten FDA approval time for urgent situations like AIDS
Switching policy of FDA, from Rx to OTC
Based on need to reduce cost
New drugs are always made prescription for at least 3 years before considering their conversion to OTC status
Good safety record
Used frequently to demonstrate a need
Non-prescription drug categories
I - safe and effective
II - unsafe or ineffective
III - not sure, requires more studies
On and off
not FDA approved, but confirmed by research and clinical experience
label use of prescriptions
FDA policy regarding herbal products
treats them as dietary supplements or food
Labeling requirements for herbals
These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent any disease
Labeling of herbals controlled by
FTC - Federal Trade Commission
