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Section 1

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What established that drugs must be safe?

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Government Law Politics

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Last updated

6 years ago

Date created

Mar 1, 2020

Cards (25)

Section 1

(25 cards)

What established that drugs must be safe?

Front

Food, Drug, and Cosmetic Act

Back

Manufacturers can disseminate off-label uses

Front

FDA Modernization Act

Back

Drug Wholesalers must be Licensed by states

Front

Prescription Drug Marketing Act

Back

Thalidomide Tragedy

Front

Kefauver-Harris Amendment

Back

Safe & Effective

Front

Kefauver-Harris Amendment

Back

Banned Reimportation except for Manufacturers

Front

Prescription Drug Marketing Act

Back

Established cGMPs

Front

Kefauver-Harris Amendment

Back

Label/ Labeling

Front

Food Drug, and Cosmetic Act

Back

Fast Track

Front

FDA Modernization Act

Back

Market Exclusivity

Front

Patent Term Restoration Act

Back

USC vs ARS

Front

Back

FDA lost its authority to regulate dietary supplements before they hit the market

Front

DSHEA

Back

Misbranding/ Adulteration

Front

Food, Drug, and Cosmetic Act

Back

Created the ADNA

Front

Patent Term Restoration Act

Back

Established ADE Reporting

Front

Kefauver-Harris Amendment

Back

Established oral (& telephone) prescriptions

Front

Durham-Humphrey

Back

AAC vs CFR

Front

Back

Poison Packaging Protection Act is enforced by what agency

Front

Consumer Product Safety Commission

Back

Sample regulation

Front

Prescription Drug Marketing Act

Back

What gave the FDA authority over medical devices?

Front

Medical Device Amendment

Back

Sulfanilamide Elixir Tragedy

Front

Prompted the Food, Drug, and Cosmetic Act

Back

Established refills

Front

Durham-Humphrey

Back

Patient Treatment with Investigational Drugs (& Serious Diseases)

Front

FDA Modernization Act

Back

Established OTC & RX classes

Front

Durham-Humphrey

Back

Patent Term Extensions

Front

Patent Term Restoration Act

Back