drug approvals Flashcards
phase 3 clinical trials
- randomized control trials
- usually just one dose (guided by phase 2 data)
- thousands of patients
- less monitoring, “more real world”
- duration (detect more safety events)
- efficacy and safety
drug approvals
approved by health canada or FDA
- for intended use
- for intended patient population
- rely mainly on phase 3 clinical trial data
risk decisions
- how safe is safe enough?
- population
- individual
review process
- health canada evaluates the safety, efficacy, and quality of data
TPD assesses the potential benefits and risks of the drug using the above
option 1 review process
option 1: decision to approve
- benefits can outweigh the risks
- risks can be dealt with
- drug issues a notice of compliance
- drug issued a drug identification number, is officially approved in canada
option 2 review process
option 2: deny approval
- sponsor can supply additional information
- sponsor can re-submit later with additional data
- sponsor can appeal decision
fast-track in canada
- faster review for drugs for life-threatening or severe conditions
phase 4
pre-market clinical studies involve 1000s of patients
- demonstrated efficacy with statistical confidence
- provide sufficient information of risk-benefit without unnecessarily taxing time/resources and limiting patient access to medications
- any study preformed after drug approval
- looks at safety over time
premarket trials
- populations evaluated are restricted
- more intensive monitoring vs. real world
drug recalls
FDA can recall drugs due to
- drug manufacturing/purity
- drug causes mild or major side effects
- a drug can be on the market for many years and still be recalled
emergency use authorization (EUA)
during an emergency ex. pandemic
- Increases availability of unapproved medication/vaccine
- not the same as FDA approval
