Federal Pharmacy Laws and Regulations

Question 1

What FDA center is responsible for reviewing drug data provided by the manufacturer in order to make sure that the drugs marketed in the US are safe and effective?

Answer 1

CDER - Center for Drug Evaluation and Research

Question 2

When is an IND filed?

Answer 2

If the pre-clinical animal research indicates a relatively safe drug with a potential therapeutic use

Question 3

What does an IND indicate?

Answer 3

FDA’s permission to begin Phase I clinical studies on human subjects

Question 4

What clinical study phase’s purpose is to evaluate the dosing range?

Answer 4

Phase II

Question 5

What clinical study phase’s purpose is to evaluate the PK and PD of a drug?

Answer 5

Phase I

Question 6

What clinical study phase’s purpose is to evaluate the efficacy for treating the condition compared to a placebo or gold-standard treatment?

Answer 6

Phase III

Question 7

What clinical study phase’s purpose is to evaluate the side effects, adverse effects, and safety of the drug?

Answer 7

Phase I

Question 8

When is the NDA filed?

Answer 8

After Phase III, before marketing

Question 9

What is the expected turn-around time for CDER to review NDAs, per PDUFA?

Answer 9

PDUFA (Prescription Drug User Fee Act) - CDER expected to review 90% of applications for standard drugs within 10 months of receiving the application, and within 6 months for priority drugs

Question 10

What is a BLA?

Answer 10

Biologics license application (BLA) - like an NDA, but for biologics

Question 11

When is an sNDA needed?

Answer 11

Supplemental NDA - needed to change a label, add a new indication, add new dosage or strength of a drug, or change the way it manufacturers a drug

Question 12

What sections are required in a package insert?

Answer 12

Indications and usages
Dosage and administration
Dosage forms and strengths
Boxed warnings (if present)
Contraindications
Warnings and precautions
Adverse reactions
Drug interactions
Use in specific populations (peds, pregnancy, nursing, geriatrics)
Description
Clinical Pharmacology
Clinical Studies
References
How supplied/storage & handling
Patient counseling information

Question 13

What are the pathways in which an OTC drug is approved?

Answer 13

NDA or “three-phase public rulemaking process”

Question 14

When is an ANDA needed?

Answer 14

Abbreviated NDA - for generic drug approval (does not require pre-clinical animal studies and clinical studies with human subjects

Question 15

What is REMS?

Answer 15

Risk Evaluation and Mitigation Strategy (REMS) - required for drugs with serious ADRs that may require additional training or information provided to patients and providers to ensure awareness of potential serious ADRs

Question 16

What drugs have an NDC number but aren’t listed in the Orange Book?

Answer 16

Unapproved drugs - i.e. drugs marketed before 1938 that were grandfathered in

Question 17

What agency regulates advertising of prescription drugs?

Answer 17

FDA

Question 18

What agency regulates advertising of OTC drugs?

Answer 18

FTC (Federal Trade Commission)

Question 19

Does a drug advertisement require FDA approval?

Answer 19

No, but the FDA will get involved if the information is false, misleading, or lacking fair balance

Question 20

What minimum information is required in a drug advertisement?

Answer 20

Name of drug (brand and generic)
At least 1 FDA-approved use for the drug
The most significant risks of the drug