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ProtectionHumanSubjectsSpring2022-CLASS_Four_Part_3_with_notes (1) (3) (2).pdf

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1Human Experimentation:Methodological IssuesFundamentalsWeek4-Part1Spring 2022Mary Dronitsky, JD, MBA, MSN
2Week ThreePart ThreeProcess of Clinical Trials
3IntroductionFDA regulates drugs, biologics and devices used in the diagnosis,cure, mitigation, treatment or prevention of disease even if exemptfrom IND or IDE requirements in humans and animalsFDA conducts rigorous review of drugs, biologics and medical devicesfor safety and efficacy for an indication prior to granting approval formarketingFDA and Sponsor draft and negotiate the package insert/approvedlabeling before product is marketedApproved labeling summarizes what FDA has determined to be safeand effective use of the productFDA regulates drugs, biologics and devices used in the diagnosis, cure,mitigation, treatment or prevention of disease even if exempt from IND or IDErequirements in humans and animals.FDA conducts a rigorous review of drugs, biologics and medical devices forsafety and efficacy for a given indication prior to granting approval for marketing.FDA and Sponsor draft and negotiate the package insert or approved labelingbefore product is marketed.Summarizes what FDA has determined to be safe and effective use of theproduct
4IntroductionClinical studies conducted according to the approvedlabeling exempt from Investigational New Drug (IND)and Investigation Device Exemption (IDE) regulationsFDA does not exempt these studies from human subjectprotection regulationsAll research studies with FDA regulated productsinvolved in human studies require IRB reviewExemption from IND/IDE regulations is not anexemption from IRB reviewFurther clinical studies conducted according to the approved labeling are exemptfrom Investigational New Drug and Investigation Device Exemption regulations.IND/IDEFDA does not exempt these studies from the human subject protectionregulationsAll research studies with FDA regulated products that involve human studiesrequire IRB reviewExemption from IND/IDE regulations is not an exemption from IRB review
Stages of Drug Development"Science& Research."Industry-FDA Interactions During Drug Development.U.S. Food and Drug Administration,Mar.2004.Web.14Apr.2012.<PathOpportunitiesReports/ucm077262.htm>.85
Stages of Medical Device Development777Class I -General Controls; Most exempt from premarket submission ExampleDental FlossClass IISpecial Controls; Premarket Notification[510(k)] Example-ThermometerClass IIIPremarket Approval; Require Premarket Application[PMA]ExampleReplacement Heart Valves76
7Drugs and Biologics INDsRequired for human research with biologics or drugs notapproved by FDAFDA reviews IND applications and will allow humanexposure only if risks of exposure are reasonableIND application generally includes:Evidence of safety and tolerability in animalsControlled method of manufacture that assures theconsistency of final drug productToxicology studiesWell-developed research plan that minimizes risk forhuman volunteersRequired for human research with biologics or drugs not approved by FDAFDA reviews these applications and will allow human exposure only if it feelsrisks of exposure are reasonableIND application generally includes:Evidence of safety and tolerability in animals

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Clinical trial

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