FDA BRIEF: Week of January 9, 2017

fda guidances


OVERVIEW: >100 documents, list reflects draft and revised draft guidances under development at the time of this release

CATEGORIES: Advertising, Biopharmaceutics, Biosimilarity, Clinical/Antimicrobial, Clinical/Medical, Clinical Pharmacology, Clinical/Statistical, Drug Safety, Electronic Submissions, Generics, Labeling, Pharmaceutical Quality/CMC,  Pharmaceutical Quality/Manufacturing Standards, Pharmacology/Toxicology, Procedural, User Fee



OVERVIEW:  Problems with analysis and interpretation of results of study with multiple endpoints & management of problems of false conclusions if no adjustment for multiplicity


  • Hierarchy of Families of Endpoints
  • Type II Error Rate and Multiple Endpoints.
  • Types of Multiple Endpoints.
  • Individual Components of Composite and Other Multi-Component Endpoints


  • Type I Error Rate for a Family of Endpoints and Conclusions on Individual Endpoints
  •  When the Type I Error Rate Is Not Inflated or When the Multiplicity Problem Is Addressed Without Statistical Adjustment or by Other Methods
  • Common Statistical Methods for Addressing Multiple Endpoint-Related Multiplicity Problems



OVERVIEW: Clarity regarding principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical studies; to run trials in an efficient and cost-effective manner, while maintaining appropriate patient and research participant protections


  • Informed Consent and IDE decisions
  • IDE application assessment in the context of device development pathway
  • Assessing benefits and risks for IDE applications
  • Recommended General Framework for benefit-risk assessment
  • Hypothetical examples of summary benefit-risk assessment
  • Reference guide
  • Risk management terms



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