Table of Content

Chapter 1 Introduction
1.1 Study Goals and Objectives
1.2 Scope of Report
1.3 Information Sources
1.4 Analyst’s Credentials

Chapter 2 Governing Authority and Drug Development
2.1 Governing Regulatory Authority
2.2 Drug Development
2.2.1 Market Entry of Nonprescription Drug Products Under OTC Monograph
2.2.2 CDER Small Business and Industry Assistance (CDER SBIA)
2.2.3 Application Types
2.2.4 FDA Approval
2.2.5 Drug Development Designations

Chapter 3 Generic Drugs
3.1 Approval Process for Generic Drugs
3.2 Abbreviated New Drug Application (ANDA)

Chapter 4 New Drug Application (NDA)
4.1 Guidance Documents for NDAs
4.2 Laws, Regulations, Policies and Procedures
4.2.1 Code of Federal Regulations (CFR)
4.2.2 CDER’s Manual of Policies and Procedures (MaPPs)
4.2.3 Prescription Drug User Fee Act (PDUFA)
4.2.4 NDA Forms and Electronic Submissions
4.2.5 Advisory Committees
4.3 Electronic Regulatory Submissions and Review
4.3.1 Electronic Common Technical Document (eCTD)
4.3.2 FDA Electronic Submissions Gateway (ESG)
4.4 Drug Recalls
4.4.1 Alerting the Public
4.4.2 Weekly Enforcement Report
4.4.3 Determining the Effectiveness of the Recall