Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
Author : Gloria Hall
Publisher :
Page : pages
File Size : 11,49 MB
Release : 2020-03-06
Category :
ISBN : 9781947493414
Author : Gloria Hall
Publisher :
Page : pages
File Size : 11,49 MB
Release : 2020-03-06
Category :
ISBN : 9781947493414
Author :
Publisher :
Page : pages
File Size : 38,82 MB
Release : 2014-05-23
Category :
ISBN : 9780989802864
Compilation of the pharmaceutical and biologics chapters from Fundamentals of US Regulatory Affairs Eighth Edition and Fundamentals of International Regulatory Affairs Second Edition,
Author :
Publisher :
Page : pages
File Size : 38,95 MB
Release : 2016
Category :
ISBN : 9780996949156
Author :
Publisher :
Page : pages
File Size : 14,37 MB
Release : 2014-05-23
Category :
ISBN : 9780989802888
Compilation of pharmaceutical and biologics chapters from Fundamentals of EU Regulatory Affairs Sixth Edition, Fundamentals of Canadian Regulatory Affairs Fourth Edition and Fundamentals of Japanese Regulatory Affairs First Edition.
Author : Regulatory Affairs Professionals Society
Publisher :
Page : 0 pages
File Size : 45,49 MB
Release : 2023-05
Category :
ISBN : 9781947493865
Author : Javed Ali
Publisher : Academic Press
Page : 287 pages
File Size : 10,84 MB
Release : 2021-11-14
Category : Medical
ISBN : 0128222239
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Author : Zeeshaan Arshad
Publisher :
Page : 252 pages
File Size : 14,31 MB
Release : 2017
Category : Biologicals
ISBN : 9780997769739
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
Page : 169 pages
File Size : 41,63 MB
Release : 2020-04-25
Category : Medical
ISBN : 0309498635
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author : Institute of Medicine
Publisher : National Academies Press
Page : 442 pages
File Size : 32,78 MB
Release : 2011-04-03
Category : Medical
ISBN : 0309158060
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author : David Mantus
Publisher : CRC Press
Page : 402 pages
File Size : 23,94 MB
Release : 2014-02-28
Category : Medical
ISBN : 1841849197
FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.