exam 1- drug approval & development Flashcards
(19 cards)
1962: Kefauver-Harris amendment
-require meds 1938-1962 to be demonstrated not only safe but effective
-FDA oversees drug ads
-established cGMP
-added requirements to clinical investigation
how often does a manufacturer need to undergo inspection
at least once every 2 years
-no cGMP = adulterated
-don’t register w/ FDA = adulterated and misbranded
when making drugs, what are the 3 categories
503a
503b
manufacturing
describe a 503a
Pharmacy or Traditional Compounding
-compound pursuant to prescription, for individual patient, and done by pharmacist/physician
-ingredients used must be bulk
-cannot be copy of commercially available product
-compounding done in advance on limited basis
what are the 503a exemptions
cGMP
misbranding
new drug requirements
describe 503b
outsourcing facilities
-compounded w/o receiving a prescription for specific patient
-must register, pay fees, and inspected by FDA
-compounding cannot be a copy of commercially available product
-product labels must contain the following
what must 503b product labels contain
-statement “this is compounded”
-Name/addy/phone of facility
-lot or batch #
-established name
-dosage or strength
-quantity of volume
-BUD
-storage/handling instructions
-NDC
-statement “not for resale”
-list of all ingredients
what are DESI drugs
investigates all drugs between 1938-1962
drugs remain on market until decision is made
what happens during preclinical research
in vivo animal testing utilized to record data on toxicity and pharmacology of the product
what must IND contain
animal pharmacology/toxicology studies
manufacturing info
clinical protocols and investigator information
what happens in clinical research phase 1
-evaluated the safety and dosage of the compound
-baseline human pk and pharmacologic properties are also reviewed and reported
what happens in clinical research phase 2
determine the effectiveness of the therapy
what happens in clinical research phase 3
several geo locations
demonstrate efficacy at a higher power, and to expand info around adverse effects
what happens in new drug application
everything is submitted to the FDA from the studies and include
-proposed labeling
-safety updates
-drug abuse info
-patient info
-any data from studies that have been conducted outside the US
-institutional review board info
-directions for use
what happens in post marketing surveillance phase 4
FDA reviews medwatch for trends among AEs
what is the orphan drug act
provided lower statistical burdens for proof of safety and efficacy when appropriate and allowed
-tax incentives
-enhance patent protection
-clinical research subsidies
-government incentives
before hatch-waxman act
FDA approval for generic cannot be started until patent expires
generics had to perform own studies
after hatch-waxman act
generic companies can prep for approval w/o hinging on patent
only prove bioequivalence and acceptable manufacturing
explain abbreviated new drug application
applicant does not need to include trial data to establish safety/efficacy
