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Jurisprudence > Exam 1 - Lecture 2 > Flashcards

Exam 1 - Lecture 2 Flashcards

1
Q

“New Drug” info

A
  1. no person can introduce “new drug” into interstate commerce unless approved by FDA
  2. law prohibits shipment of any new drug into interstate commerce without FDA approval, need NDA to get drug approval
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2
Q

How can approved drug become a new drug?

A
  1. Addition of new substance
  2. New combo of approved drugs
  3. Change in proportion of ing
  4. New intended use
  5. Dosage, method, or duration of admin or app is changed
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3
Q

What required for NDA?

A
  1. evidence that the drug is safe and effective, obtained from animal and clinical studies
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4
Q

What does IND allow you to do?

A

IND allows you to conduct animal and clinical studies

it reg info about the drug, its manufacturing, and the experience/qualifications of clinical investigator

** reg before clinical trials **

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5
Q

Phase I

A

.

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6
Q

Phase II

A

.

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7
Q

Phase III

A

.

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8
Q

Informed consent

A
  1. intended to protect the human research subjects

2. required for patient participation in phase 1-3 clinical trials

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9
Q

What must informed consent contain?

A

** 45 CFR part 46; 21 CFR Part 50 ** where the info is

  • explanation of purpose
  • description of procedures
  • description of foreseeable risks
  • description of any benefits may be seen
  • disclosure of appropriate alternative procedures
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10
Q

Info included in NDA

A
  1. Details of drug chemistry
  2. Preclinical trials
  3. Manufacturing processes
  4. Clinical Trials
  5. Packaging and labeling
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11
Q

Prescription Drug Fee User Act of 1992

A

allowed FDA to collect fees from drug manufacturers to fund the new drug approval process

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12
Q

Changes to approved NDA are filed using….

A

Supplemental New Drug Application

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13
Q

SNDA

A
  • req when manufactures makes any change in approved drug or its production
  • 3 categories
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14
Q

“CBE” SNDA

A

Change being effected SNDA

allows sponsor to make change before FDA approval and is important in labeling changes

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15
Q

21st Century Cures Act and New Drug Approval

A
  1. Passed 2016, designed to accelerate medical product development
  2. streaming and adding flexibility to drug dev & approval process
  3. encourages consideration of novel clinical trial design and “real-world evidence”
  4. Expanded orphan drug program
  5. reauthorized FDA voucher program for Rare Pediatric Disease***
  6. program for approval of antimicrobial resistant drugs for limited populations
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16
Q

Phase 4 - Post Market Surveillance

A
  1. once NDA approved, manufacturer can legally distribute drug into interstate commerce
  2. manufacture must establish and maintain a post-market records and reports
  3. Serious ADR and any new safety info must be submitted to FDA
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17
Q

Food and Drug Administration Amendments Act of 2007 (FDAAA)

A
  1. empowered FDA to req phase 4 when Adverse event reporting or active surveillance isn’t enough
  2. gave FDA authority to req manufacturers to add safety info or warning postmarket
  3. FDA maintain website for pt and providers with info
  4. started “sentinel Initiative” designed to detect early signs of drug risk
  5. FDA authority to req REMS as condition of approval
  6. req pharmacies to provide pts with MedWatch number and statement about reporting side effects
18
Q

MedWatch

A

Voluntary reporting system maintained by the FDA that allows healthcare professionals to report serious adverse events, including serious drug side effects, product use errors, product quality problems, and therapeutic failures

19
Q

Drug Efficacy Study Implementation (DESI)

A
  1. Implemented 1968, retroactive to 1938 for efficacy requirement
  2. Created ANDA for generic drugs approval
20
Q

ANDA info

A

requires only evidence of bioequivalanece and manufacturing methods rather than proof of safety and efficacy

21
Q

U.S Supreme Court ruled that generic drugs are…

A

new drugs and subject to FDA approval

22
Q

6 Categories drugs classified as under national Academy of Sciences National Research Council

A
  1. Effective
  2. Probably effective (additional evidence req)
  3. Possibly effective (little evidence submitted)
  4. Ineffective (no acceptable evidence)
  5. Effective but (safer/better drugs exists)
  6. Ineffective as a combo
23
Q

Efficacy Review of OTC Medications

A

Classified as Categories 1-3

1: generally recognized as safe, effective and not misbranded
2. not generalized as safe and effective or are misbranded
3. insufficient data available to classify the ingredient

24
Q

Hatch - Waxman Amendement 1984

A

Drug Price Competition and Patent Term Restoration Act

  1. Created statutory generic approval process
  2. established ANDA process
  3. allowed for greater generic competition
  4. enhanced protection for innovators

** certain non-patent exclusives (Orphan drug 7yrs)

25
Q

Orange book

A

tells you which medications are equivalent

26
Q

Purple book

A

Lists biologic products, including biosimilars and interchangeable products

27
Q

Food and Drug Administration Modernization Act (FDAMA) of 1997

A
  1. Widespread patient treatment
  2. Individual Patient Access
  3. Expanded Access (Compassionate use)
28
Q

FDA will only approve treatment with an IND if….

A
  1. Serious or immediately life-threatening disease or condition
  2. No comparable or satisfactory alternative therapy is available
  3. Clinical trials for the IND are for the disease or condition
  4. The sponsor is actively seeking approval of drug
  5. For serious disease- there is sufficient evidence of safety and effectiveness for the use
  6. For immediate life-threatening disease- there is reasonable basis that the drug may be effective and would not expose the patient to unreasonable and significant risk
29
Q

Individual Patient Access - Parallel Track Policy

A

An individual pt acting through physician may request an IND (Phase 2/3) for treatment of serious disease or condition

** If sufficient evidence of safety/efficacy and it won’t interfere with clinical trial **

30
Q

Expanded Access (a.k.a Compassionate use)

A

Potential pathway for pt with life-threatening condition to try drugs with no alternate therapy available

can even use phase I

31
Q

When is Expanded access appropriate?

A
  1. Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
  2. There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
  3. Patient enrollment in a clinical trial is not possible.
  4. Potential patient benefit justifies the potential risks of treatment.
  5. Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
32
Q

What patients are eligible for Expanded Access?

A
  1. Been diagnosed with a life-threatening disease or condition
  2. Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying)
  3. And has provided, or their legally authorized representative has provided written informed consent regarding the eligible investigational drug to the treating physician
33
Q

Expedited “Fast Track” Approval

A

accelerate approval of new drugs for serious or life-threatening illnesses

address unmet needs (Fast Track) or substantial improvement on clinically significant endpoint (Breakthrough)

approval conditioned on completion of post marketing or Phase 4 clinical trials

34
Q

EUA

A

Pandemic and All-Hazards Preparedness Reauthorization act of 2013

35
Q

What is a biologic?

A

Replicate natural substances such as enzymes, antibodies, or hormones in our bodies

36
Q

Medical Device Amendments of 1976

A

authorized FDA to approve medical devices

3 Classifications of devices, Class I, II, III

37
Q

Class I device

A

least harm to users, general controls are adequate to ensure safety and effectiveness. General controls include registering facility with FDA, listing their products with the FDA, following GMP, maintain records and reports and premarket notification in some cases.

ex. scissors, needles, stethoscopes, toothbrush

38
Q

Class II device

A

general controls alone are insufficient to ensure safety and effectiveness. Must meet specific performance standards established by the FDA before marketing approval granted by FDA.

ex. insulin syringes, infusion pumps, thermometers, tampons, electric heating pads

39
Q

Class III device

A

require pre-market approval because the devices are life-supporting or life-sustaining or present potential unreasonable risk of illness or injury.

ex. implantable pacemakers, breast implants

40
Q

Do cosmetics have same approval process of drugs?

A
  1. No premarket approval, nor conformance with CGMP
  2. Manufacturers must substantiate product safety.
  3. The FDA may remove if misbranded, adulterated, or a health hazard.
  4. Must be labeled with list of ingredients in descending order of predominance and appropriated warnings
41
Q

Can cosmetics be misbranded?

A

Cosmetics may be misbranded if its labeling is false, misleads the consumer, or lacks the required information, or if its label information is not clear enough to be read by the ordinary consumer

42
Q

Cosmetics can be adulterated if…

A
  1. It contains any poisonous or deleterious substances that may injure users
  2. It contains filthy, putrid, or decomposed substance
  3. It is prepared under unsanitary conditions
  4. The container contains a substance that may contaminate the contents
  5. It contains unsafe color additives but is not a hair dye***

**hair dyes that contain coal tar are EXEMPT from the adulteration and color additive provisions of the law

Jurisprudence (5 decks)

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