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Pharm-Drug Approval

Drug Approval

what authority does the FDA have over drug development and use (4) 1) requires demonstration of drug efficacy; 2) demonstration of safety; 3) regulate drug testing and manufacture; 4) force withdrawal
the FDA has oversight of drug development and usage, with what exceptions (3) 1) does not regulate non-prescription drug advertising; 2) prescription drug advertising reviewed, but not pre-approved; 3) DEA regulates controlled substances
what is the first form to submit for drug approval IND (investigational new drug)
what is required before IND is submitted chemistry / animal testing
what cannot happen before IND is submitted human testing
what is the next form that needs to be submitted NDA (new drug application)
what is needed to support the NDA clinical studies
how many phases of clinical studies are there three
what part of drug approval requires the most time and resources clinical trials
how much can it cost for developing a new molecular entity one hundred million dollars and more
what is a new IND required for (2) with the same drug 1) each dosage form; 2) each disease target
what is the IND approval process like they are not approved, but are put on a "clinical hold" by the FDA within 30 days - if there is no hold placed, the sponsor may proceed
what must the sponsor continually send the FDA, as far as the IND (3 - forms/reports, not general information) 1) annual IND reports; 2) IND amendments that describe change in trials; 3) safety reports
what are three pieces of general information that must be included in the IND application 1) description of drug (chemical analysis, stability); 2) description of drug product (e.g. tablet); 3) proposed drug labeling to guide IND clinical investigators
what is some pharmacologic/toxicology information expected to be included in the IND (3) 1) MOA/effects in animals; 2) absorption/metabolism/distribution/elimination (pharmacokinetics) studies in vitro and in animals; 3) toxicology
what types of toxicology studies are done (2) 1) acute; 2) chronic
what information is necessary for a NDA application (3) 1) information from IND; 2) new data from animal studies; 3) clinical data from phase 1-3 trials
what things are looked at in phase 1 studies (3) 1) metabolism; 2) drug/food interactions; 3) adverse effects
what things are looked at in phase 2 studies (3) 1) dose-ranging; 2) detailed pharmacokinetics; 3) first efficacy data
what things are looked at in phase 3 studies (2) definitive safety/efficacy studies
what % of drugs successfully get through phase 1, 2, and 3 70%, 33%, 25-30%
when must NDA reports be submitted once a drug is approved, and for how long every year, as long as the drug is marketed
what is post-marketing reporting (NDA annual reports) focused on drug safety
what were two "problem areas" of adverse effects that have led to drug withdrawal 1) hepatic toxicity; 2) promotion of ventricular arrhythmias
how effective is adding "black box" warnings to problem drugs FDA considers it to be ineffective
what are "risk management action plans" when the FDA approves limited access to high-risk drugs if medically necessary
what example was given thalidomide for leprosy, despite risk of phocomelia
what conditions are placed on thalidomide prescription (3) 1) restricted set of prescribers; 2) patient registry; 3) agree to use two types of birth control
what does ANDA stand for abbreviated new drug application
what is ANDA meant for generic versions of previously approved drugs
what is not necessary in an ANDA repetition of clinical safety/efficacy studies
what must the company show in the ANDA application that drug is identical (chemical analysis, formulation process, pharmacokinetics)
what is the purpose of the orphan drug act (what three things are provided, and for what purpose) provides: 1) research grants; 2) tax credits; 3) and extended exclusive marketing for drugs that treat rare diseases
what are examples of drugs (and their uses) that are covered in the orphan drug act (2) 1) digoxin immune Fab (for digoxin toxicity); 2) imatinib (Gleevac) for CML
what constitutes a "rare disease" <200,000 patients/year
what are "treatment INDs" and who do they apply to allows patients not in clinical trials to use drugs at phase 3 stage - only applies for seroius conditions for which there is no approved alternative treatment
what drugs are eligible for accelerated development those meant for life-threatening and severly debilitating illnesses; drugs may have to address unmet clinical needs
Created by: mcafej02