PUBLISHER: BCC Research | PRODUCT CODE: 1147802
PUBLISHER: BCC Research | PRODUCT CODE: 1147802
Regulatory Intelligence Report for Pharmaceuticals in the U.S.
Highlights:
This report presents an understanding of the regulations and requirements of companies in the U.S., as well as foreign companies or establishments planning to manufacture, distribute or market their pharmaceuticals in the U.S. This report provides a brief about the related regulations for registration of the establishments and pharmaceuticals.
Report Scope:
The current report provides detailed exposure to regulatory requirements for pharmaceuticals marketing and registration in the USA. This report highlights the current regulations and comprehensive procedure for the registration, renewal, or notification of the pharmaceuticals, along with the information on the timeline and fee required. The report also focuses on the labeling and advertising regulations for the pharmaceutical and the process for the registration of the product with any specific variation. These regulations would be helpful for the premarketing of the pharmaceutical in the U.S. market.
Report Includes:
- A brief general outlook of the current market scenario of regulatory requirements for pharmaceuticals marketing and registration in the U.S.
- Highlights of the current regulations and comprehensive procedure for the registration, renewal, or notification of the pharmaceuticals, along with the information on the timeline and fee required
- Emphasis on the labeling and advertising regulations for the pharmaceutical and the process for the registration of the product with any specific variation
- Coverage of the technological, economic, and business considerations of pharmaceuticals regulatory scenario and premarketing of the pharmaceutical in the U.S. market
Table of Contents
Chapter 1 Introduction
- 1.1 Study Goals and Objectives
- 1.2 Scope of Report
- 1.3 Information Sources
- 1.4 Analyst's Credentials
- 1.5 Related BCC Research Reports
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
