Federal Part 1

Question 1

What is the the FDA responsible for?

Answer 1

Protecting the public health by ensuring safety, efficacy, and security of drugs, biologics, and med devices

Question 2

How many centers are in the FDA?

Answer 2

6

Question 3

According to the US pharmacopoiea, what is a drug?

Answer 3

Substances intended for use in diagnosis, cure, prevention of disease in people or animals

Question 4

Is soap a cosmetic?

Answer 4

No

Question 5

What is the definition of dietary supplement?

Answer 5

Substances used to supplement diet by increasing TDI

Question 6

Who is involved in pre-clinical testing?

Answer 6

Animals to determine therapeutic use

Question 7

What is the First application form submitted by the sponsor to the FDA before the drug can be administered to humans?

Answer 7

Investigational New Drug
* FDA permission for phase 1 trials

Question 8

Purpose for IND?

Answer 8

1. Safety in humans
2. Proper design of studes
3. COnduction of human trials

Question 9

Once the IND has been submitted, the FDA has ___ days to decide if the drug is suitable for testing?

Answer 9

30

Question 10

What do phase 1 trials assess

Answer 10

Safety of drugs in humans

Several months

Question 11

What does phase II trials assess?

Answer 11

Safety and efficacy

Several months - 2 yrs

Question 12

What is assessed in phase III trials?

Answer 12

Effectvieness compared to a control group recieving a placebo

Years

Question 13

How many subjects are in a trial

Answer 13

PI: Small number of healthy individuals
PII: 100+ with dx
PIII: 300-1000 patients

Question 14

Who is responsible for conducting clinical trials?

Answer 14

PI: sponsoring company
PII: sponsoring company
PIII: Idependent investigators at clincal sites

Question 15

What phase determines dosage range?

Answer 15

Phase 1

Question 16

What phase is a blinded study

Answer 16

Phase 2 and 3

Question 17

What phase obtains info about adequate dosage and ADRs?

Answer 17

Phse 2

Question 18

Drug that is not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drug’s labeling

Answer 18

New drug

Question 19

The FDA has ___ days to act on a new drug application

Answer 19

180 days
* most apps are reviewed within 10 months

Median review time was reduced to 15 months

Question 20

What is the BLA?

Answer 20

New drug application for biologics

Question 21

What is the FDA expedited review program?

Answer 21

Reduces a drug’s FDA review period from ten months to six (both NDA and BLA)

Question 22

What is a fast track?

Answer 22

Drugs intended to meet unmet med needs without treatment existance or drugs that offer substantial benefits over existig treatments

Question 23

Drugs must show early clinicalevidence of substantial improvement over existing therapies

Answer 23

Breakthrough therapy

Question 24

Intendedfor drugswith long-term endpoints, such as increased survival or decreased morbidity, which are difficult to measure efficiently in trials

Answer 24

Accelerated approval

Question 25

How can an approved drug be considered new? What is the application called?

Answer 25

1. New substance 2. New comboniation 3. Proportion of ingredients 4. New intended use 5. Changes in dosage, method, and admin Supplemental New drug app (SNDA)

Question 26

How long is the exclusivity of SNDAs?

Answer 26

3 yrs

Question 27

Generic drug approvals?

Answer 27

1. ANDA 2. 505(b)(2) application

Question 28

Does ANDA hrequire studies?

Answer 28

Not pre or clinical studies, but must provide data comparing to branded drug

Question 29

Generic drug requirements?

Answer 29

1. Same active ingredient 2. Same route 3. Same dosage form 4. Same strength 5. Bioequivalent 6. Inactive ingredients can be different

Question 30

What is the 505 b 2 app?

Answer 30

Drug can be marketed in different strength or fomulation than the branded

Question 31

First applicant to complete a formal review showing bioequivalence to brand product granted ____ of exclusivity

Answer 31

6 months

Question 32

Approved Drug Products with Therapeutic Equivalence Evaluations

Answer 32

Orangebook

Question 33

What is the TE codes?

Answer 33

A: therapeutically equvalent B: not therapeutically equivalent Second letter describes dosage form or nature of product

Question 34

Used to assist healthcare professionals with interchanging biosimilars

Answer 34

Purple book

Question 35

What is the purple book coding system?

Answer 35

B: biosimilar (can't be substituted for reference product by pharamacist without PA) I: interchangeable (can be subbed without prescriber intervention)

Question 36

Will unapproved drugs appear in the orange book?

Answer 36

No, but will have an NDC

Question 37

What is Phase IV trials

Answer 37

Used to obtain long-term safety and efficacy * New uses and abuses * Post marketing surveillance

Question 38

How often are manufacturersrequired to submit post-market surveillance?

Answer 38

Annually

Question 39

Voluntary reporting system that allows healthcare professionals to report ADRs, errors, and quality problems?

Answer 39

MedWatch

Question 40

MedWatch is exclusive to prescribers

Answer 40

No, FDAAA brodened it to include patient and consumer reports

Question 41

How often are ADE required to be reported by the manufacturer?

Answer 41

Quarterly for first 3 yrs after approval, then annually

Question 42

WHat is REMS?

Answer 42

Used for drugs that have high potential for harm: * Special training * Specific dispensing settings * Patient enrollment and monitoring

Question 43

Provides FDA-approved patient-friendly labeling of ADRs, directions, and risks?

Answer 43

MedGuide

Question 44

Does the FDA directly communicate the risks of REMs to the patient?

Answer 44

FDA approved materials -> Healthcare providers -> Patient via communication plan

Question 45

Requires medical interventions or other actions by healthcare professionals prior to prescribing or dispensing the drug

Answer 45

Elements to assure safe use (ETASU) Ex: dispensig naloxone with fentanyl

Question 46

When is an implementation system used?

Answer 46

Severe ADRs, limiting distribution or access program for the drug: * Open distribution * Managed distribution * Controlled distribution * Restricted access

Question 47

Drug product may cause serious adverse health consequences including death

Answer 47

Class 1 recall

Question 48

Drug product may cause temporary or reversible effects

Answer 48

Class II recall

Question 49

Drug product is unlikely to cause any adverse health consequences

Answer 49

Class III

Question 50

Manufacturers must notify the FDA ___ days prior to withdrawing a product from sale

Answer 50

180

Question 51

Who regulates prescription drug ads?

Answer 51

FDA

Question 52

Who regulates OTC ads?

Answer 52

FTC

Question 53

Does advertisements need to be approved by the FDA?

Answer 53

No, but will get involved if there has an ad of fallse and misleading information

Question 54

Ads must include:

Answer 54

1. Name (brand an generic) 2. At least of one FDA approved indication 3. Most significant risks

Question 55

Implemented in 2010 to enlist healthcare professionals to help ensure that company promotion of prescription drugs is truthful

Answer 55

Bad Ad program

Question 56

Customer benefits of drug ads?

Answer 56

1. Education 2. Awareness 3. Compliance 4. Lowers drug prices

Question 57

Pharmacist benefits of drug ads?

Answer 57

1. Increase Rx bus 2. Greater public recognition

Question 58

COns of drug ads?

Answer 58

1. Raises health care 2. Inappropriate demand of drugs 3. Confuse patients 4. Jeopardize patient-physician relationship

Question 59

How should drug ads be advertised in pharmacies?

Answer 59

1. Price 2. Propetary name of the drug 3. Established name 4. Strength 5. Dosage forms 6. Price chargerd