fda guidances


Updated Process for Qualification of Drug Development Tools (DDT) Under New FD&C Act Section 507

DDT Qualification to follow updated, multi-stage process under 21stCentury Cures Act 

  • 3 submission milestones: Letter of Intent (LOI), Qualification Plan (QP), Full Qualification Package (FQP)2
  • Transparency provisions and public posting of information by FDA
  • To transition from legacy qualification program process to new section 507 DDT Qualification Process

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Good Review Practice: Clinical Consultative Review of Drugs Regulated with OND

Describes  clinical consultative review process in the CDER Office of New Drugs (OND)  for INDs, NDAs, BLAs, and supplemental NDAs and BLAs

  • To gather expertise of second review division because of familiarity with drug for other uses, expertise in another aspect of disease or organ system

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Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions

Form 3674: All Drug, Biologic, Device Submissions require certification that all applicable requirements have been met (implemented in 2007)

  • Form FDA 3674 can be obtained at LINK
  • Requires submitter to confirm compliance with all applicable requirements of Title VIII, including applicable implementing regulations, e.g., the requirement to register applicable clinical trials
  • Guidance to provide clarifications and additional details

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Validated Instructions for Use and Validation Data Requirements for Resuable Medical Devices

 

List of reusable medical devices for which the FDA will require for premarket submissions:

  • validated instructions for use
  • validation data regarding cleaning, disinfection, and sterilization
  • in accordance with the requirements of 21st Century Cures Act
  • facilitates 510(k) reviews

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E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs — Questions and Answers (R3)

ICH E14 guidance Clinical Evaluation of QT/QTc Interval Prolongation finalized in 2005

  • This guidance for clarifying key issues
  • Sex Differences, Incorporating New Technologies, Concentration-Response Relationships, Combination Products, Large Targeted Proteins and Monoclonal Antibodies, and Special Cases, Use of Concentration Response Modeling

Overview

  • Electrocardiograms Methodology
  • Gender
  • Positive Control
  • Study Design
  • Concentration Response Modeling
  • Special Cases
  • Electrocardiograms monitoring in late stage clinical trial

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