Regulatory Class - Parts of a NDA Flashcards
Parts of a NDA
Administrative Items Index Labeling Application Summary Chemistry, Manufacturing, and Controls Nonclinical Pharmacology and Toxicology Human Pharmacokinetics and Bioavailability Microbiology (only for antibiotic drugs) Clinical Data Safety Update Reports Statistics Pediatric Use Case Report Form Tabulations Case Report Forms
Parts of a NDA: Administrative Items
Application Form (FDA Form 356h) Patent Information Patent Certification Establishment Description (certain biological drugs) Debarment Certification Field Copy Certification User Fee Cover Sheet (FDA Form 3397) Financial Certification or Disclosure (FDA Form 3454 or 3455) Other Information
Parts of a NDA: Application Summary
Proposed Annotated Package Insert (Labeling)
Pharmacologic class, scientific rationale, intended use, potential clinical benefits
Foreign Market History
CMC Summary
Nonclinical Pharmacology and Toxicology Summary
Microbiology Summary (only for antibiotic drugs)
Clinical Data Summary and Results of Statistical Analysis
Discussion of Benefit/Risk Relationship
Parts of a NDA: Application Summary: Clinical Data Summary and Results of Statistical Analysis
Clinical pharmacology Overview of clinical studies Controlled clinical studies Uncontrolled clinical studies Other studies and information Safety Summary (general safety conclusion) Overdose and drug abuse
Parts of a NDA: CMC
Description of the Drug Substance
Description of the Drug Product
Samples
Methods Validation Package
Parts of a NDA: CMC: Drug Substance
Name/designation of drug substance Structural overview Physical and chemical characteristics Reference standard Detailed info on drug substance manufacturing site Manufacturing methods Container and Closure requirements Drug substance analytical controls Drug substance stability
Parts of a NDA: CMC: Drug Product
Drug product components/composition
Inactive ingredients
Where drug product is manufactured, tested, and packaged
Drug product - manufacturing methods
Drug product packaging
Drug product analytical controls
Drug product stability
Drug product investigational formulations
Environmental assessment or claim for exemption
Parts of a NDA: Nonclinical Pharmacology and Toxicology
Summary
Individual Study Reports (-Pharmacology, -Toxicology, -ADME studies)
Parts of a NDA: Human Pharmacokinetics and Bioavailability
Tabulated summary of studies Summary of data and overall conclusions Drug formulation information Analytical methods Dissolution data Individual Study Reports (-Pilot or background studies, -Bioavailability/bioequivalence studies, -Pharmacokinetic studies, -Other in vivo studies, -In vitro studies)
Parts of a NDA: Clinical Data
List of investigators and list of INDs and NDAs
Background/overview of clinical investigations
Clinical pharmacology
Controlled clinical trials
Uncontrolled clinical trials
Other studies and information
Integrated Summary of Effectiveness data
Integrated Summary of Safety information
Drug abuse and overdose information
Integrated summary of all benefits and risks of the drug
