FDA Regulatory Affairs

Abstract

OVERVIEW OF DRUG DEVELOPMENT AND THE FDA, D.J. PisanoBrief History of Drug Laws and RegulationsRegulatory Oversight of PharmaceuticalsNew Drug Approval and DevelopmentPreclinical InvestigationInvestigational New Drug Application (INDA)Phase IPhase IIPhase IIINew Drug Application (NDA)PDUFA/FDAMA EffectsBiologicsOrphan DrugsAbbreviated New Drug Applications (ANDA)Phase IV and Postmarketing SurveillanceOver-The-Counter (OTC) RegulationsRegulating MarketingViolations and EnforcementSummaryREGULATORY STRATEGY, J. DombroskiIntroductionOverview of a Regulatory StrategyRegulatory Strategies for Different Phases of Product DevelopmentConclusionsWHAT IS AN IND? R. Pietrusko and T. ClassWhat is an IND?Pre-IND MeetingThe Content and Format of an IND ApplicationMaintaining an IND: IND Amendments and Other Required ReportsOther Types of INDsPromotion and Charging for Investigational DrugsMore Information About INDsFORMATTING, ASSEMBLING, AND SUBMITTING THE NEW DRUG APPLICATION (NDA), D. Pizzi and J.C. RaeFDA GuidelinesAssembling Applications for SubmissionNDAThe NDA in CTD FormatMEETING WITH THE FDA, A. GrignoloTypes of FDA MeetingsFDA ExpectationsPreparing for FDA MeetingsConduct at FDA MeetingsAvoiding the PitfallsSpecific Meeting ObjectivesConclusionBIOLOGICS, J. Kenimer and J.J. JessopDefinition of a Biologic ProductThe Center for Biologics Evaluation and Research (CBER)Preclinical Issues Unique to Biological ProductsThe Biologics License Application (BLA)The Future of Biologics RegulationFDA MEDICAL DEVICE REGULATION, B. SallIntroductionIs It a Device?Medical Device ClassificationAn Introduction to the Medical Device Approval ProcessDesign ControlsMedical Device Clinical ResearchThe 510(k) Premarket NotificationThe Premarket Approval ApplicationThe Quality System Regulation (QSR)Postmarketing IssuesTHE DEVELOPMENT OF ORPHAN DRUGS, M.E. HaffnerIntroductionFDA Office of Orphan Products DevelopmentThe Designation ProcessTax CreditsPDUFA and Orphan Products DevelopmentOrphan Product Grants ProgramClinical Trial Design for Rare Disease TreatmentAccomplishmentsGOOD CLINICAL PRACTICES, R. BuckleyIntroductionHow Research Was DoneThe Need for Global Standards in ResearchWhat are the GCPs? Regulations and GuidanceGCP-Sponsor ObligationsSponsor Oversight of Clinical StudiesDocumentation/Reporting of Study MonitoringFDA's Oversight of Clinical StudiesSponsor's "Unbiased" Oversight of Clinical StudiesGCP: A Complete Sponsor EffortFrequently Asked QuestionsAttachmentsWeb ResourcesGOOD MANUFACTURING PRACTICES (GMPS) AND ENFORCEMENT ACTIONS, C. Hay and F. KaltovichIntroductionRegulationsCurrent Good Manufacturing PracticesFDA Enforcement ActionsReporting ChangesThe Role of the Regulatory Affairs Professional in cGMPsRisk-Based GMP ApproachSummaryELECTRONIC SUBMISSI