Drug Act Abbreviations

Question 1

PFDA

Answer 1

Pure Food and Drug Act
1906
First law directed to protecting the public from food and drugs

Question 2

FDCA

Answer 2

Food Drug and Cosmetic Act
1938
The nucleus of the FDA as we know it today; drugs had to be safe after enacted

Question 3

DHA*

Answer 3

Durham Humphrey Amendment
1951
Established the two classes of drugs: prescription and OTC
AKA Prescription Drug Amendment

Question 4

FAA

Answer 4

Food Additives Amendment

1958

Question 5

CAA

Answer 5

Color Additive Amendments

1960

Question 6

KHA*

Answer 6

Kefauver Harris Amendment
1962
Drugs after 1938 needed to be safe AND effective

Question 7

MDA

Answer 7

Medical Device Amendments

1976

Question 8

FTC

Answer 8

Federal Trade Commission

Question 9

GMP

Answer 9

Good Manufacturing Practices

Question 10

FDA

Answer 10

Food and Drug Administration

Question 11

ODA*

Answer 11

Orphan Drug Act
1983
Provides incentives for manufacturers to develop and market drugs for rare diseases/conditions

Question 12

DPC/PTRA*

Answer 12

Drug Price Competition and Patent Term Restoration Act
1984
Facilitated the approval process of generic drugs
AKA Waxman Hatch Amendment

Question 13

PDMA*

Answer 13

Prescription Drug Marketing Act
1987
Established requirements for prescription drug sample distributions
Prohibits resale of pharmaceuticals by hospitals and other healthcare entities

Question 14

SMDA

Answer 14

Safe Medical Devices Act

1990

Question 15

GDEA

Answer 15

Generic Drug Enforcement Act

1992

Question 16

PDUFA*

Answer 16

Prescription Drug User Fee Act
1992
Requires manufacturers to pay application fees for NDAs

Question 17

NLEA

Answer 17

Nutrition Labeling and Education Act

1990

Question 18

DSHEA*

Answer 18

Dietary Supplement Health and Education Act
1994
Created the class of supplements called dietary supplements
Required FDA to regulate these as more food than drug

Question 19

FDAMA

Answer 19

Food and Drug Administration Modernization Act
1997
Streamlined regulatory procedures to expedite the availability of drugs and devices
Created a fast track process for drugs intended for serious or life threatening diseases

Question 20

MDUFMA

Answer 20

Medical Device User Fee and Modernization Act

2002

Question 21

FDAAA*

Answer 21

Food and Drug Administration Amendments Act
2007
Provided the FDA with significantly enhances authority to regulate drug safety

Question 22

ACA

Answer 22

Patient Protection and Affordable Care Act

2010

Question 23

FDASIA*

Answer 23

FDA Safety and Innovation Act
2012
Added user fees for generic drugs and biosimilars

Question 24

DQSA*

Answer 24

Drug Quality and Security Act
2013
Clarified the law related to pharmacy compounding

Question 25

Cures Act*

Answer 25

The 21st Century Cures Act 2016 Streamlines and adds flexibility to the drug development and approval process Allows for more patient experience say during the approval process

Question 26

FDARA

Answer 26

FDA Reauthorization Act | 2017

Question 27

REMS*

Answer 27

Risk Evaluation and Mitigation Strategies | Part of the FDCAAA

Question 28

The Delaney Clause

Answer 28

``` FAA and CAA requires the (FDA) to ban food additives which are found to cause or induce cancer in humans or animals as indicated by testing ```