1. FDA Health Psychology

2. FDA = Food & Drug Administration Part of Dept of Health & __________ Services

3. Products FDA Regulates Food & ___________ Supplements Drugs Medical Devices Biologics Animal Feed & Drugs Cosmetics ___________ - Emitting Products

4. Stage 1: Preclinical Research Drug Discovered ___________ Research –Harmful effects –How works FDA: Investigational New Drug Application

5. Stage 2: Clinical Research ___________ clinical trials Overseen by: –pharmaceutical co –physicians –regulatory authorities –safety & ethics committee

6. Phase I ___________ volunteers, not taking other meds Small groups Determines: How body processes, responds to, is affected by drug Test low & high ___________

7. Phase II Pts w/ disease or disorder only, no other meds Small controlled trials Determines: drug's _______________, side effects, general effectiveness

8. Phase III Pts w/other diseases/disorders, other meds Large controlled trials ___________

9. Phase IV After initial FDA approval Specific populations More safety investigations

10. Stage 3: FDA Review & Approval New Drug Application –pharm co reports all results to FDA Approval if safe & ___________

11. Stage 4: Marketing Drug available to drs & pts For ___________ only Maybe research on other uses

12. Controlled Trials Placebo: pt thinks getting something ___________ _______: all get some drug Active-tx: other known effective drug No tx Historical: compare past mortality rates

13. Placebo Types Sugar pills Waiting History-taking Injections _________________ Active placebos

14. Placebo effects ~ ___% of clinical effect Often bigger than drug’s effect Placebo addiction & withdrawal

15. Individual characteristics Older Women ___________ Hi neuroticism

16. Psych Factors Expectancy –Faith, hope, suggestibility –Pt & ________ –Pos & neg Credibility –Of dr & tx –Ointment<pill<injection

17. Mechanisms Spontaneous remission Classical conditioning Cognitive theory _______________ Physiological explanations