FDA BRIEF: Week of Nov. 21, 2016

fda guidances


BCG.JPG

PURPOSE:  Assist in clinical development of drugs, biologics, for the treatment of patients who have bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC

DEVELOPMENT PROGRAM

  • Early Phase
  • Late Phase

GENERAL CONSIDERATIONS

  • Trial Population and Entry Criteria
  • Randomization, Stratification, and Blinding
  • Dose Selection
  • Single-Arm vs. Randomized, Controlled Trial Design
  • Efficacy Endpoints
  • Trial Procedures and Timing of Assessments
  • Endpoint Adjudication
  • Statistical Considerations
  • Accelerated Approval (Subpart H and Subpart E) Considerations
  • Risk-Benefit Considerations

OTHER CONSIDERATONS

  • Risk Management Considerations
  • Nonclinical Safety Considerations

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ped.JPG

PURPOSE: Current regulatory perspective on topics in pediatric drug development

ETHICAL CONSIDERATIONS & SCIENTIFIC APPROACH

AGE CLASSIFICATION

  • Subgorups
  • Neonates

OPTIMIZATION

  • Use of Existing Knowledge in Pediatric Drug Development
  • Use of Extrapolation in Pediatric Drug Development
  • Use of Modelling and Simulation in Pediatric Drug Development

PRACTICALITIES

  • Feasibility
  • Outcome Assessments.
  • Long-term Clinical Aspects, including safety

PEDIATRIC FORMULATIONS

  • Dosage and Administration
  • Excipients.
  • Palatability and Acceptability
  • Neonates

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safety.JPG

PURPOSE: When and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated

GENERAL CONCEPTS

  • Approaches for Assessing Metabolite Safety
  • Identification of Metabolites
  • General Considerations for Nonclinical Study Design

RECOMMENDED STUDIES

  • General Toxicity Studies
  • Genotoxicity Studies
  • Embryo-Fetal Development Toxicity Studies
  • Carcinogenicity Studies

TIMING
DECISION TREE FLOW DIAGRAM
CASE EXAMPLES

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contract.JPG

PURPOSE: Defining, establishing, and documenting manufacturing activities  for  contract drug manufacturing  and Current Good Manufacturing Practice (CGMP) requirements

DEFINING : Who, What

RESPONSIBILITIES

DOCUMENTING CGMP ACTIVITIES

  • Quality Agreemen
  • Manufacturing Activities.
  • Change Control

ILLUSTRATIVE SCENARIOS

  • Owners and Contract Facilities Are Both Responsible for CGMP
  • CGMPs Apply to all Contract Facilities, Including Analytical Testing Laboratories
  • Owners and Contract Facilities Perform Change Control Activities

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cp-label

SCOPE: Assist applicants in preparing CLINICAL PHARMACOLOGY section of prescription drug labeling

  • to meet regulatory requirements
  • ensure appropriate consistency in the format and content

GENERAL PRINCIPLES

  • Content and Organization
  • Cross-Referencing

SUBSECTIONS

  • Mechanism of Action
  • Pharmacodynamics
  • Pharmacokinetics: Absorption, Distribution, Elimination, Specific Populations, Drug Interaction, Microbiology, Pharmacogenomics

PRESENTATION

  • Central Tendency and Variation
  • Presentation Format

PROCEDURAL

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