This book is a roadmap to the U.S. Food and Drug Administration and drug, biologic, and medical device development. It is written in plain English, with an emphasis on easy access to understanding how this agency operates with respect to the practical aspects of U.S. product approval. It is meant to be a concise reference that offers current, real-time information. It has been written as a handy reference for use by students, staff, and professionals at corporations, organizations, and schools and colleges across the United States in need of a simple, concise text from which to learn and teach. The topics in FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition are covered in a straightforward format. It is a compilation and commentary of selected laws and regulations pertaining to the development and approval of drugs, biologics, and medical devices in the United States. It is not intended to take the place of an actual reading of the Laws of the United States of America or the regulations of the U.S. Food and Drug Administration, it’s agencies or any body that regulates the development or approval of drugs, biologics, and medical devices in the United States.
Drug Regulatory Affairs Book
Nature of offer : Sell
Company Name : United Books & Periodicals
Year of Establishment : 1981
City & State : Mumbai, Maharashtra
Country : India
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his is the first comprehensive overview of the legal and regulatory framework for marketing authorization applications in Europe, including Switzerland. It gives extensive and valuable advice on how to compile
a marketing authorisation according to the CTD format (Modules 1 – 5 CTD).
The ’Guide’ is subdivided into four major parts
- Part A: This provides detailed information about different procedures for drug approval, and relevant legislation and requirements that have to be considered when submitting an application for marketing authorisation. Judicial decisions from pertinent European courts are also highlighted.
- Part B: This gives detailed practical advice on how to prepare an application for marketing authorisation and also the accompanying documents which demonstrate quality, safety and efficacy. In addition, aspects of maintaining the marketing authorisation are discussed, covering applications for variations to a marketing authorisation, extension applications and renewal applications. Regulatory compliance issues are considered, and the requirements for IMPDs (Investigational Medicinal Product Dossiers) are included. Marketing authorisation procedures and the regional part of a Swiss marketing authorisation application are also considered.
- Part C: This describes the main provisions relevant to biopharmaceuticals, plant-based traditional medicinal products, blood, blood products and orphan drugs.
- Part D: This includes much additional helpful information: an index of abbreviations, an index of terms and definitions, literature, links etc.
Available as a print or online edition, the ‘Guide’ is a multi-media resource designed to support the different needs of its users.