Regulatory Intelligence Report for Pharmaceuticals in the U.S.
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"
- 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
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