Oberon's RAC Drugs Exam Questions With Complete Answers!!
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Module
Oberon\'s RAC Drugs
Institution
Oberon\'s RAC Drugs
TEA process - 21 CFR 330-14
add established ingredient to existing OTC monograph
Request for Designation (RFD) - ask FDA if it is a drug, biological, device, combo
HDE humanitarian device excempt - no effectiveness data required
misbranded device - not cleared through 510k process (but needs on...
Oberon's RAC Drugs TEA process - 21 CFR 330 -14 add established ingredient to existing OTC monograph Request for Designation (RFD) - ask FDA if it is a drug, biological, device, combo HDE humanitarian device excempt - no effectiveness data required misbranded device - not cleared through 510k process (but needs one) adultered device - does not have PMA but needs one design input for device - requirements that must be met IDE (Investigational Device Exemption) - report within 5 working days: emergencies, use without informed consent, IRB withdrawal/approval unanticipated events: 10 working days Class II Device - Requires 510(k). Substantial equivalence to already marketed device. Requires general and special controls to ensure safety and effectiveness. Special controls may include mandatory performance standards, patient registries for implantable devices and postmarket surveillance. may require clinical trials. Class III Devices - require PMA (pre -market approval). FDA has 180 days to accept/reject application QSR - Quality System Regulation (21 CFR 820). Identifies GMPs for medical devices. device post -market reporting - serious events: 30 days. public health risk: 5 days. kinds of 510(k) - special (your own device modifications, 30 day review time) abbreviated (conforms to recognized standard, 15 days review time) traditional (90 days review time) PMA types - traditional modules (alternative: PDP product development protocol) 180 day supplement (device) - supplement to an approved premarket application that requests significant changes abbreviated 501k - special controls exist special 501k - device is under 510k already, minor modifications do not affect use OTC monograph amendments - TEA, citizen's petition FDAMA 1997 - orphan drug exempt from fees (can seek waiver) fees for IND phase biosimilars - Biosimilar User Fee Act 2012 FDA - public proceedings - 5 types: advisory committee meeting public regulatory hearing (by commissioner) public workshop board of inquiry evidentiary hearing Public Regulatory Hearing - 21 CFR16 by commissioner, determines PMA/IRB disqualification Fast Track Review - unmet medical needs rolling review FDAMA 1997 Priority Review - FDA to take action within 6 months neglected, rare pediatric diseases PDUFA 1992 no clinical data required breakthrough - clinical evidence showing better than what is available QIDP designation - fast-track, 5 years exclusivity (qualified infectious disease product) suitability petition - ANDA - product is different from approved drug (90 days) citizen's petition - ANDA - asking FDA to refrain from certain regulations (180 days) (action requested, environmental impact, statement of grounds, economic impact, certification) CDRH meetings - presubmission, early collaboration, submission issue (discuss deficiencies), PMA day 100 (review status) FDA type A meeting - "critical path meeting", stalled program, 30 days of FDA receipt of written request + receipt of package FDA type B meeting - 60 days after request FDA type C meeting - 75 days after request PMA - pre-market approval (device) adverse event during IND - report within 7 days quality system does not include - test+ article characterization (GLP) Directive 2001/83/EC - medical products for human use Directive 2001/20/EC - clinical trials Regulation EC 726/2004 - centralized authorization procedure, EMA established article 58 applications - medicine is used extensively outside EU Regulation EC 141/2000 - orphan drugs (10 years market exclusivity) CEC - central ethics committee (EU)
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