What does the NDA contain a complete evaluation of ?
What is NDA approval based on?
- drug’s safety and efficacy
- Based on proof of safety and efficacy, the manufacturing, & risk–benefit ratio
What can NDA summary and data include?
4
- drug chemistry
- Preclinical trials & Clinical trials
- Manufacturing
- Packaging & labeling
What does the Prescription Drug Fee User Act allow the FDA to do?
collect fees from drug manufacturers to fund the NDA process
What does the USP set?
Is it a private or public org?
What does it work closely with?
Sets uniform drug standards
private
FDA
What does the The Homeopathic Pharmacopeia of U.S. (HPUS) set?
Is it a private or public org?
- set uniform Standards for homeopathy products
- private organization
What does the Medical Device Amendment require (3)?
- pre-market approval
- GMP compliance
- record and reporting requirement
What does the Patient Protection and Affordable Care Act contain a subtitle to facilitate?
Afforded Care Act (ACA) or Obamacare
- to facilitate approval of generic biologics (a.k.a. biosimilars)
Amendment to FD&C
What does the Kefauver-Harris Amendment require? What did it establish? What did it transfer?
- evidence of effectiveness for intended use
- Established GMP requirement
- Transferred oversight of drug advertising from FTC to FDA
drugs must be proven effective as well safe to be
approved
Response: Drug Efficacy Study Implementation (DESI)
What was the US Supreme Court rule?
- Generic drugs are new drugs and subject to FDA approval
Ensure all drugs (including older ones) are proven effective in response to the Kefauver-Harris Amendment, which added the efficacy requirement
Response: Drug Efficacy Study Implementation (DESI)
Was the efficacy requirement of Kefauver-Harris applied retroactively or from the date of the amendedmnt to the drugs?
retroactively to all drugs marketed - includes innovator and generics
required for all drugs — even those already on the market since 1938.
What was the Drug Efficacy Study Implementation (DESI) in response to?
Kefauver-Harris amendment’s efficacy requirement
How did the National Research Council take on the task of evaluating each Rx medication individually?
- divided the task among 30 panels of experts within 6 categories
Effective
Probably effective (additional evidence required)
Possibly effective (little evidence submitted)
Ineffective (no acceptable evidence)
Effective… but (a better, safer or more conveniently
administered drug is available)
Ineffective as a combination
What the efficacy requirement from the Kefauver-Harris amendment include
How were OTC products reviewed?
- innovators, generics, and OTC
- by class
How were the OTCs classified under the Kefauver-Harris amendment?
What helped to place the OTCs in the classes?
Category I: generally recognized as safe, effective and not
misbranded
* Category II: not generally recognized as safe and effective or that
are misbranded
* Category III: insufficient data available to classify the ingredient
1. Monographs of ingredients
What are the 3 classifications of Medical devices?
Class 1 - low risk - toothbrush
Class 2 - moderate risk - FDA clearance + 510k premarket notification to FDA - ultrasound
Class 3 - high risk, life support devices - FDA approval + clinical trials + PMA - pacemakers
Response: Drug Efficacy Study Implementation (DESI)
What did the efficacy requirement of Kefauver-Harris to all drugs cause for the FDA?
Who did the FDA commission study the drugs and
submit recommendations to the FDA.
How are OTC & Rx evaluated?
burdened the FDA.
commissioned the National Academy of Sciences National Research Council
OTC evaluated by Class
Prescription Drugs evaluated individually
Response: Drug Efficacy Study Implementation (DESI)
For generic Drugs, what process did the FDA use?
- abbreviated process - ANDA
* Making the requirement retroactive for innovator and generics burdened the FDA. Several thousand drugs
had been marketed between 1938-1962.
* The FDA commissioned the National Academy of Sciences National Research Council to study the drugs and
submit recommendations to the FDA. OTC evaluated by Class. Prescription Drugs evaluated individually.
How did the Kefauver-Harris Amendment strengthen clinical trials?
by requiring informed consent of research subjects and adverse drug reaction
reporting
What does the Purple book list?
biologic products
What do biologic do?
What specific biologics does the FDA regulate?
- replicate natural substances
- blood and blood components
gene therapy products
human tissue and cellular products used in
transplantation
Vaccines
Allergy extracts
What authorized the FDA to review medical devices?
Medical Device Amendment
under the FD&C Act, does the FDA have the authority to review medical devices for safety and/or efficacy before marketing?
- No
Which segment of the NDC shows package size? specific drug?
- package size - last 2 digits
- specific drug - mid 4 digits
What is an NDC #
10-digit code that
identifies the
manufacturer, product,
and package size of
prescription and OTC
medications
