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MPJE Law > Federal Part 1 > Flashcards

Federal Part 1 Flashcards

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1
Q

What is the the FDA responsible for?

A

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

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2
Q

How many centers are in the FDA?

A

6

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3
Q

According to the US pharmacopoiea, what is a drug?

A

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

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4
Q

Is soap a cosmetic?

A

No

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5
Q

What is the definition of dietary supplement?

A

Substances used to supplement diet by increasing TDI

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6
Q

Who is involved in pre-clinical testing?

A

Animals to determine therapeutic use

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7
Q

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

A

Investigational New Drug
* FDA permission for phase 1 trials

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8
Q

Purpose for IND?

A
  1. Safety in humans
  2. Proper design of studes
  3. COnduction of human trials
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9
Q

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

A

30

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10
Q

What do phase 1 trials assess

A

Safety of drugs in humans

Several months

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11
Q

What does phase II trials assess?

A

Safety and efficacy

Several months - 2 yrs

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12
Q

What is assessed in phase III trials?

A

Effectvieness compared to a control group recieving a placebo

Years

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13
Q

How many subjects are in a trial

A

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

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14
Q

Who is responsible for conducting clinical trials?

A

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

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15
Q

What phase determines dosage range?

A

Phase 1

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16
Q

What phase is a blinded study

A

Phase 2 and 3

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17
Q

What phase obtains info about adequate dosage and ADRs?

A

Phse 2

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18
Q

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

A

New drug

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19
Q

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

A

180 days
* most apps are reviewed within 10 months

Median review time was reduced to 15 months

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20
Q

What is the BLA?

A

New drug application for biologics

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21
Q

What is the FDA expedited review program?

A

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

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22
Q

What is a fast track?

A

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

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23
Q

Drugs must show early clinicalevidence of substantial improvement over existing therapies

A

Breakthrough therapy

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24
Q

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

A

Accelerated approval

25
Q

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

A
  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)

26
Q

How long is the exclusivity of SNDAs?

A

3 yrs

27
Q

Generic drug approvals?

A
  1. ANDA
  2. 505(b)(2) application
28
Q

Does ANDA hrequire studies?

A

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

29
Q

Generic drug requirements?

A
  1. Same active ingredient
  2. Same route
  3. Same dosage form
  4. Same strength
  5. Bioequivalent
  6. Inactive ingredients can be different
30
Q

What is the 505 b 2 app?

A

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

31
Q

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

A

6 months

32
Q

Approved Drug Products with Therapeutic Equivalence Evaluations

A

Orangebook

33
Q

What is the TE codes?

A

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

34
Q

Used to assist healthcare professionals with interchanging biosimilars

A

Purple book

35
Q

What is the purple book coding system?

A

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

36
Q

Will unapproved drugs appear in the orange book?

A

No, but will have an NDC

37
Q

What is Phase IV trials

A

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

38
Q

How often are manufacturersrequired to submit post-market surveillance?

A

Annually

39
Q

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

A

MedWatch

40
Q

MedWatch is exclusive to prescribers

A

No, FDAAA brodened it to include patient and consumer reports

41
Q

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

A

Quarterly for first 3 yrs after approval, then annually

42
Q

WHat is REMS?

A

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

43
Q

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

A

MedGuide

44
Q

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

A

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

45
Q

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

A

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

46
Q

When is an implementation system used?

A

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

47
Q

Drug product may cause serious adverse health consequences including death

A

Class 1 recall

48
Q

Drug product may cause temporary or reversible effects

A

Class II recall

49
Q

Drug product is unlikely to cause any adverse health consequences

A

Class III

50
Q

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

A

180

51
Q

Who regulates prescription drug ads?

A

FDA

52
Q

Who regulates OTC ads?

A

FTC

53
Q

Does advertisements need to be approved by the FDA?

A

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

54
Q

Ads must include:

A
  1. Name (brand an generic)
  2. At least of one FDA approved indication
  3. Most significant risks
55
Q

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

A

Bad Ad program

56
Q

Customer benefits of drug ads?

A
  1. Education
  2. Awareness
  3. Compliance
  4. Lowers drug prices
57
Q

Pharmacist benefits of drug ads?

A
  1. Increase Rx bus
  2. Greater public recognition
58
Q

COns of drug ads?

A
  1. Raises health care
  2. Inappropriate demand of drugs
  3. Confuse patients
  4. Jeopardize patient-physician relationship
59
Q

How should drug ads be advertised in pharmacies?

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

MPJE Law (2 decks)

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