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level: Level 2

Questions and Answers List

level questions: Level 2

Question	Answer
Generic products MUST BE BIOEQUIVALENT in comparison to approved proprietary drug FOCUS on BIOEQUIVALENCE TESTING than safety and efficacy Bioquievalent - rate and extent of drug absorption must be within established parameters to the reference drug	Abbreviated New Drug Application (ANDA)
rate and extent of drug absorption must be within established parameters to the reference drug	Bioquievalent
Abbreviated New Drug Application (ANDA) __ may be issued if approval of the generic drug occurs prior to the expiration dates of patents or exclusivities of the reference drug	Tentative Approval Letter delaying the marketing of the generic product
Intended to TREAT SEVERELY DEBILITATING or life THREATENING ILLNESSES Regulations are made to EXPEDITE the DEVELOPMENT and APPROVAL PROCESS FDA are allowed to approve a new drug BASED ON SURROGATE ENDPOINT (likely to predict therapeutic response)	Rapid Access To New Drug Products
FDA are allowed to approve a new drug BASED ON __ (likely to predict therapeutic response)	SURROGATE ENDPOINT
are intended to make drugs that are relatively far along in the development Process AVAILABLE TO SERIOUSLY ILL PATIENTS and AVAILABLE DURING PHASE III clinical trials	Treatment INDs
FDA policy to focused on pts with clinically significant illnesses who CANNOT BE ENROLLED IN ON-GOING TX TRIALS. → receive tx in an OPEN-LABEL DESIGN before safety and efficacy have been established	Parallel track
Drugs used to TREAT RARE DISEASES Same process with FDA but expedited Orphan Drug Act of 1983- tax incentives, reduced user fees, exclusivity agreements	Orphan drugs
tax incentives, reduced user fees, exclusivity agreements LAW for Orphan drugs	Orphan Drug Act of 1983
DIFFERENT FROM RX DRUGS and review is NOT HELD AS SAME STANDARDS WITH NDA 1st phase- involved ADVISORY PANEL consist of multidisciplinary group of scientists FDA review all statements and publishes tentative final monograph Final monograph is published and goes effect ONE YEAR after publication Recognized as safe, effective, NOT MISBRANDED Following the monograph, company can market OTC drug without additional approval from FDA	Over The Counter Drug Approval
Drug safety is still monitored Sponsors must submit reports of adverse events periodically Newly approved drugs- filed quarterly for the first 3 years, then annually AE considered as serious and unexpected- sponsor provides written report to FDA within 15 days of receipt of info	Safety monitoring
filed quarterly for the first 3 years, then annually	Newly approved drugs
Newly approved drugs are filed quarterly for the first__, then annually	3 years
__ - health providers reports ADR to FDA, ALERTS PRACTITIONERS regarding actions and recommendations by FDA AE→ requires minor label changes, addition of warning or precautions statements FDA may also withdraw NDA	FDA MedWatch program
CHANGES TO AN APPROVED PRODUCT ANY CHANGE made to an FDA- approved drug product- components, chemical synthesis, analytical methods, manufacturing site, process, batch size, labeling- must be reported 1 __ - requires FDA approval prior to implementation of change	1 Scale-up and Post-approval Changes (SUPAC)