FDA COPY

Question 1

1. What is the FDA led by?
2. How are they appointed?
3. What does the FDA often rely on?

Answer 1

1. A Commissioner
2. Appointed by the President (w/ Senate
   confirmation)
3. 4. An advisory committee

Question 2

Evidence a product is a drug

Answer 2

labeling
advertising
nature of product

Question 3

Define Food

Answer 3

articles used for food or drink for man or other animals
- articles used for components of any such article

Question 4

Can food ever be considered a
drug? If so, any exceptions?

Answer 4

Food must be used for its ordinary purpose (e.g., eating for nutrition, taste, or enjoyment).

If it’s marketed or used to treat or prevent disease, it may be classified as a drug instead

• Exception - Medical Foods and special dietary
  foods (health claims in labeling)

Question 5

Health Claims for Food

What claims can be made ONLY be drug products?

Answer 5

1. Products intended for use in the prevention,
   mitigation, and treatment of a disease

Question 6

Define cosmetics
What does it exclude?

Answer 6

1. intended to be applied on to the body for cleansing, beautifying, promoting attractiveness, or altering the appearance, and
   (2) excludes soap.

Question 7

Can a cosmetic become a drug? How

Answer 7

If the seller makes a health or structure/function claim
- if intended to treat or prevent
disease or affect the structure or functions of the body

Note: “Ignorant, unthinking consumer” standard
likely applied

must comply with both the drug and cosmetic provisions of the law.

Question 8

Define devices
What does it affect?
What does it not use?

Answer 8

An instrument, machine, or implant intended for diagnosis, cure, treatment or prevention

Affects the structure of the body

Does not achieve its purpose by chemical action or metabolism

excludes any that use chemical action or metabolism

Question 9

New drug

True or false: The FD&C Act states that a “new
drug” can be introduced into interstate commerce without FDA approval by the FDA.

Answer 9

False
- need FDA approval

Question 10

How does the FD&C Act define a “new drug”?

Answer 10

A drug not generally recognized by qualified experts as safe and effective for use
as proposed by the drug’s labeling.

Question 11

How does a drug manufacturer or distributor obtains FDA approval?

Answer 11

By submitting an NDA or ANDA

Question 12

New Drug Approval

What does the law prohibit shipment of any
new drug into without FDA approval?
To obtain approval of a new drug what must be submitted?

Answer 12

1. prohibits shipment of any
   new drug into interstate
   commerce
2. NDA or ANDA

Question 13

Before filing a NDA, what must there be evidence of?

Answer 13

evidence that the drug is safe and effective
obtained from animal and clinical
studies

Question 14

To conduct clinical trials, what must the sponser file?

Answer 14

IND Application

Question 15

What does the IND require?

4

Answer 15

1. substantial info about the drug
2. manufacturing
3. experience
4. qualifications of clinical
   investigator.

Question 16

IND

What must the sponsor receive in order to ship drug in interstate commerce to conduct phase 1,2,3 clinical studies?

Answer 16

1. an approved Notice of Claimed Investigational Exemption

Question 17

1. Can the FDA terminate testing at any time?
2. What can they do it under?
3. Is the decision subject to appeal or judicial review?

Answer 17

1. Yes
2. risk–benefit criteria
3. No

Question 18

What does the FDAAA require NDA sponsors to publish?

Answer 18

summary info regarding
phase 1 trials on a public registry.

Question 19

What is informed consent intended to do?

Is it required for patient participation in clinical trials?

Are there exceptions?

How is informed consent documented in clinical trials?

Answer 19

1. protect participants
2. Yes
3. emergencies
4. must be in writing for phase I and II trials

Question 20

An approved drug can
become a new drug under
what 5 conditions?

Answer 20

1. Addition of new substance
2. New combo of approved drugs
3. Change in proportion of ingredients
4. New intended use
5. Dosage, method, or duration of administration changes

Question 21

What was the FDA’s historical approach prior to the medical device amendments?

Answer 21

1. declare devices as drugs when needed

Question 22

Rationale for having Federal Drug Regulations

Answer 22

Protect the public from adulterated and
misbranded drug products

Question 23

4 functions of the FDA

Answer 23

1. rulemaking
2. issue guidance documents
3. incorporate advice from standing advisory committees of outside experts
4. inspections/investigations

Question 24

1. Define FDA’s rulemaking authority?
2. Can the FDA issue guidance documents that are not legally binding on the public or
   the FDA

Answer 24

1. develops regulations based on FD&C Act
2. Yes

Question 25

1. Define drug 2. What does it effect? 3. Is it food?

Answer 25

1. Substance intended for use in **diagnosis, cure, mitigation, treatment, or prevention of disease** 2. Intended to affect structure or function of humans/animals 3. Non-food