PHARMA CARMELA Flashcards
Food and Drug Administration (FDA): established as an agency of
Department of Health and Human
WHEN WAS FDA ESTABLSIHED
1906
BRANCHES OF FDA
CENTER FOR DRUG EVALUATION AND RESEARCH
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
what year is food, drug, and cosmetic act approved(?)
1938
regulates safety of biologics
Childhood Vaccine Act:
what year is prescription drug fee act aprroved
1992
requires nongeneric drug and biologic manufacturers to pay fees to be used for improvements in drug review
Prescription Drug User Fee Act
requires clear labeling of dietary supplements and allows the FDA to remove those that are a risk to the public.
Dietary Supplement Health and Education Ac
Dietary Supplement Health and Education Act year
1994
FDA Modernization Act year
1997
reauthorizes the Prescription Drug User Fee Act and reforms the drug review process.
FDA Modernization Act
levels of consent
Simple consent
Inadequate consent
what are the Simple consent
express consent and implied consent
when the patient does not stop the procedure from taking place. By allowing the procedure to occur, the patient has given his or her express consent to the radiographer; however, legally, silence is not an agreement.
Express consent
occurs in emergency situations when it is not possible to obtain consent from the patient, his or her parents, or a legal representative. The health care provider operates under the belief that the patient.
Implied consent
This occurs when the patient has not been informed adequately to make a responsible decision
Inadequate consent
a contract wherein the patient voluntarily gives permission to someone to perform a procedure or service.
Consent
