Fda Regulatory Affairs

Fda Regulatory Affairs : A Guide for Prescription Drugs, Medical Devices and Biologics

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Since the enactment of the first drug law in 1848, the legislation surrounding drug development has evolved into a maze of regulations that can be hard to navigate. Not only are existing regulations constantly reviewed and updated, the increasingly rapid rate of development in the pharmaceuticals field creates new issues that need to be addressed by new legislation. Written in plain language without confusing jargon or legalese, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics provides a roadmap to the myriad and sometimes confusing regulations that govern this constantly changing field. The book examines the pertinent aspects of the Federal Food, Drug, and Cosmetic Act as they apply to human drug and device development, research, manufacturing, and marketing. It focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and the corresponding documentation requirements. Although there are a number of references on these topics, this book is unique in that it is written in a general, easy to read prose style. It presents information drawn from a wide range of resources in a single, easy to use format. FDA approval can be a lengthy and expensive process. In order for a pharmaceutical manufacturer to place a product on the market for human use, a multiphase procedure must be followed. Providing a reference for students, professionals, and especially those who are charged with the day-to-day tasks of assuring regulatory compliance under FDA guidelines, this book demystifies the inner workings of the FDA and allows you to understand how it operates with respect to product approval.show more

Product details

  • Hardback | 360 pages
  • 147.32 x 233.68 x 22.86mm | 476.27g
  • Taylor & Francis Inc
  • CRC Press Inc
  • United States
  • English
  • 53 black & white illustrations, 29 black & white tables
  • 1587160072
  • 9781587160073

Table of contents

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 SUBMISSIshow more

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