Federal law matching

Question 1

ANDA (abbreviated new drug application)

Answer 1

Application for FDA approval of a generic drug which brand name was previously approved by the FDA.

Question 2

New Drug Development Process

Answer 2

Pre-clinical testing, File IND, Clinical Trials (Phase I: healthy volunteers; Phase II: pts with dx; Phase III: large scale clinical trial), File NDA

Question 3

Poison Prevention Packaging Act of 1970

Answer 3

Mandated the use of child-resistant containers for required OTC and prescription drugs

Question 4

Patient Protection and Affordable Care Act (2010)

Answer 4

Mandated individuals to carry/purchase health insurance coverage

Question 5

Food, Drug and Cosmetic Act of 1938

Answer 5

Mandated that drugs must prove safety before marketing and that labels must contain adequate directions for use

Question 6

Dietary Supplement Health and Education Act of 1994 (DSHEA act)

Answer 6

Defined “dietary supplement”

Question 7

SNDA (supplemental New drug application)

Answer 7

Application that is filed to request a change in production of, manufacturing of, or labeling of a previously FDA approved drug product

Question 8

VAERS

Answer 8

A system that can be used to report an adverse reaction to a vaccine.

Question 9

Medwatch

Answer 9

A system that can be used to report when a patient has a serious adverse event to a medication such as a skin rash over their body

Question 10

Orphan Drug Act of 1983

Answer 10

Provided incentives for manufactures to develop and market drugs for rare disease

Question 11

REMS

Answer 11

Program designed to help determine a drug’s benefit outweighs its risks for a patient. (REMS@FDA)

Question 12

Food and Drug Administration Modernization Act of 1997 (FDAMA)

Answer 12

Allowed for fast tracking of the approval process for serious diseases and also allowed manufactures to disseminate “off-label” uses

Question 13

Omnibus Budget Reconciliation Act of 1990 (OBRA 90)

Answer 13

Intended to help to better fiscally manage Medicare and Medicaid through rebate programs, demonstrations projects, and DUR programs

Question 14

Pure Food and Drug Act of 1906

Answer 14

Prohibited the adulteration and misbranding of drugs, but did not require labels to list ingredients among other loopholes

Question 15

Durham-Humphrey Amendment of 1951

Answer 15

Established two classes of drugs: OTC and Prescription

Question 16

IND (investigational new drug application)

Answer 16

Filed before clinical trials can start; FDA has 30 days to reject before Phase I testing may begin

Question 17

Purple Book

Answer 17

Lists biologcal products including any biosimilars and interchangeable products

Question 18

Orange Book

Answer 18

Assists in ensuring generic products substituted for trade-name products are bioequivalent

Question 19

Harrison Narcotic Act of 1914

Answer 19

Mandated increased record-keeping for physicians and pharmacists who dispense narcotics.

Question 20

GMP

Answer 20

Regulations intended to ensure that the drug is safe and meets the quality and purity requirements