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Drew 914 > Block 4 -- History, FDA, Regulation > Flashcards

Block 4 -- History, FDA, Regulation Flashcards

1
Q

What are the two solid forms?

A

1) Mixture

2) Pure forms

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2
Q

Cause for 1938 FD&C Act

A

Sulfinilamide (normally tablets & powder)
Formulated into elixir sulfanilamide
– diethylene glycol
– killed > 100 people

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3
Q

What went wrong in the 2012 NECC meningitis outbreak?

A

Methylprednisolone acetate (epidural steroid injection)
Vials contaminated with mold
Compounding labs not regulated by FDA (state)
NECC became a manufacturer

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4
Q

How is particle size analyzed?

A

Sieve
Light Scattering
Microscopy

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5
Q

Particle size reduction is also known as…

A

Comminution

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6
Q

Which form of granulation is more common?

A

Wet

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7
Q

What are the 2 types of capsules?

A

Hard Gelatin

Soft Gelatin

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8
Q

Most common form of capsule?

A

Hard gelatin

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9
Q

Hard Gelatin vs. Soft Gelatin capsules:

A 
Hard: collagen, snap together
Soft: 
-- collagen + added softening agent
-- Two ribbons 
-- Used for liquids, suspensions, pastes, and solids
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10
Q

What are the range of capsule sizes?

A

000 - 5 (smallest)

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11
Q

What are types of tablets?

A
    • Compressed
    • Multiple compressed
    • Sugar coated
    • Film coated (delayed release)
    • Gelatin-coated (swallowing)
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12
Q

What is hydroscopity?

A

Amount of water taken up by a solid

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13
Q

What are the 3 types of deformation?

A

1) elastic
2) plastic
3) brittle

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14
Q

What are the axes of the BPC system?

A

Permeability & Solubility

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15
Q

Permeability limited BPC classifications?

A

3 & 4

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16
Q

Solubility limited BPC classifications?

A

1 & 2

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17
Q

Describe the history of ASA?

A
    • Hippocrates: willow bark (salicin)
    • 1839: oxidation yields salicylic acid
        • GI upset
    • 1853: neutralize with NaOH = ASA
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18
Q

Approximate number of NCE’s per year?

A

30

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19
Q

Reasons for drug reforumulation?

A

1) $
2) Fewer ADRs
3) XR technology
4) Different routes of administration

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20
Q

What is a counterfeit medicine?

A

drug sold under product name without prior authorization

– no drug, impure, or different

21
Q

Where are IND, NDA, ANDA, other reports submitted? What are they used for?

A

FDA–Center for Drug Evaluation & Research

    • id, strength, quality, purity of drug
    • support of US Pharmacopoeia monograph
22
Q

What must be contained in an NDA?

A

1) evidence of safety & efficacy
2) list of components
3) statement of composition
4) facilities, methods, and controls in manufacturing, processing, packing
5) samples of drug & labeling

23
Q

What must be contained in the IND?

A

1) detailed info regarding id, strength, quality, purity

- - final specs no required until end of IND (dosages, CMC)

24
Q

What are key CMC objectives for manufacturer?

A

1) characterize: API & product
2) quality: evidence for API & product
3) establish: manufacturing guidelines
4) control: make sure guidelines don’t change
test, test, test at all unit processes

25
Q

What is adulteration?

A

If the container is composed of poisonous or injurious substances.

26
Q

What is characterized as a class I recall?

A

Reasonable probability of serious health consequences or death.

27
Q

What is characterized as a class II recall

A
    • temporary or medically reversible consequences

- -remote probability of serious consequences

28
Q

What is characterized as a class III recall?

A

not likely to cause serious adverse effects

29
Q

What was the overall result of the poison squad?

A

Passage of the Pure Food and Drug (Wiley) Act of 1906.

30
Q

Who led the poison squad experiment?

A

Wiley.

31
Q

What did the Pure F&D Act do?

A

1) addressed interstate commerce
2) misbranding & adulteration are defined

–aka Truth Labeling Law

32
Q

What did the FD&C Act do?

A

1) required safety & NDA
2) set safe tolerances on poisonous substances
3) later amendment = Rx only

33
Q

What brought about the Kefauver-Harris Amendment?

A

Thalidomide

34
Q

When was the K-H amendment passed?

A

‘62

35
Q

When was the Pure Food & Drug Act passed?

A

1906

36
Q

When was the FD&C Act passed?

A

1938

37
Q

What were the results of the Kefauver-Harris Amendments?

A

1) effectiveness
2) FDA had to approve NDA
3) established rules of investigation
4) formalized GMP
5) required reporting of adverse events

38
Q

When was the Prescription Drug User Fee Act passed?

A

1992

39
Q

What did PDUFA do?

A

1) required fees for drug approval process

2) mutually agreed upon target review completion dates

40
Q

What brought about PDUFA?

A

’80s AIDS crisis

41
Q

How much $ is required to bring a drug to market?

A

2.5 billion dollars

42
Q

What is achieved in Phase I clinical trials?

A

Safety

–tested in healthy volunteers

43
Q

What is achieved in Phase II clinical trials?

A

Effectiveness

  • -target population
  • -placebo/comparator controlled
44
Q

What is achieved in Phase III trials?

A

Safety & Effectiveness

–different populations, dosages, combinations

45
Q

What are the target completion dates for NDA?

A

10 months

6 months if priority

46
Q

What is a BLA?

A

biologic license application

47
Q

What application is required for medical devices?

A

510k

48
Q

What is demonstrated in an ANDA?

A

bioequivalence

Drew 914 (4 decks)

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