1912: The Shirley Amendment Correct Answer -prohibited
false therapeutic claims on drug labels
-gov't had to prove attempt to defraud to remove a drug from
market
1938 Food, Drug, and Cosmetic Act Correct Answer Act that
empowered the FDA to ensure a medication is safe prior to
marketing to the public
1951 Durham-Humphrey Amendment Correct Answer This act
distinguished prescription and OTC
1962 Kefauver-Harris Amendment Correct Answer Requires
drug manufacturers to provide proof of safety and effectiveness
before marketing a drug. *thalidomide tragedy - cause birth
defects
1965 Drug Abuse Control Amendments Correct Answer
attempted to control the abuse of depressants, stimulants, and
hallucinogens.
1970 Comprehensive Drug Abuse Prevention and Control Act
Correct Answer -education, rehab, tighter controls and
enforcement
1983 Orphan Drug Act (ODA) Correct Answer Encouraged
drug companies to develop drugs for rare diseases by providing
research assistance, grants, and cost incentives to manufacturers.
, 1994 Dietary Supplement Health and Education Act Correct
Answer -expanded the definition of dietary supplements and
restricted the FDA's regulatory authority over them.
-required labeling
1996 HIPAA Correct Answer law passed to create rules and
regulations regarding the security and the privacy of all patients'
health records. provides limitations who can have access and
distribute and receive patients' health information
1997 Food and Drug Administration Modernization Act Correct
Answer 5 provisions: include: efficient, accountability, off label
information, communication
2002 Best Pharmaceuticals for Children Act Correct Answer
gives manufacturers extension of patents to evaluate drugs on
the market for their safety and efficacy in children
2003: Pediatric Research Equity Act Correct Answer FDA is
authorized to require testing by drug manufacturers of drugs and
biologic products for their safety and effectiveness in children.
2007: Food and Drug Administration Amendments Act Correct
Answer more authority
2010 Patient Protection and Affordable Care Act Correct
Answer comprehensive health care reform
2012 Food and Drug Administration Safety and Innovation Act
(FDASIA) Correct Answer advances FDAs ability to safeguard
public heath
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