米国の医薬品規制情報レポート

出版：BCC Research（BCCリサーチ）　出版年月：2022年10月

Regulatory Intelligence Report for Pharmaceuticals in the U.S.
米国の医薬品規制情報レポート

レポート目次　　お問合せ・ご注文　　価格・納期について

BCC Research（BCCリサーチ）「米国の医薬品規制情報レポート- Regulatory Intelligence Report for Pharmaceuticals in the U.S.」は米国の医薬品規制に関するポイントと簡潔にまとめています。

Report 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.

Summary:

The goals of this study are to understand 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.

Scope of Report

The current report details the regulatory requirements for medical device marketing and registration in the U.S. This report highlights current regulations and comprehensive procedures for the registration, renewal or notification of medical devices, along with information on timelines and fees required. The report also focuses on the labeling and advertising regulations for medical devices and processes for the registration of products with any specific variations. These regulations would be helpful for the premarketing of the medical device in the U.S. market.

Information Sources

BCC Research conducted primary and secondary investigations to collect data. Secondary information sources include regulatory authority websites, company websites, investor presentations, annual reports, SEC filings and corporate white papers. Information from organizations and associations, such as the FDA, and regulatory bodies is also included. The report also includes information from primary research, majorly through telephonic interviews, with key opinion leaders and subject matter experts.

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

目次

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