Regulatory Intelligence 101, Third Edition
Title | Regulatory Intelligence 101, Third Edition PDF eBook |
Author | Gloria Hall |
Publisher | |
Pages | |
Release | 2021-03-26 |
Genre | |
ISBN | 9781947493575 |
Regulatory Intelligence 101
Title | Regulatory Intelligence 101 PDF eBook |
Author | Meredith Brown-Tuttle |
Publisher | |
Pages | |
Release | 2014-08-04 |
Genre | |
ISBN | 9780967311500 |
Guide to how to conduct regulatory intelligence, available tools and resources.
Regulatory Intelligence 101
Title | Regulatory Intelligence 101 PDF eBook |
Author | Meredith Brown-Tuttle |
Publisher | |
Pages | 150 |
Release | 2016 |
Genre | Drugs |
ISBN | 9780996949118 |
Regulatory Writing: an Overview, Second Edition
Title | Regulatory Writing: an Overview, Second Edition PDF eBook |
Author | Gloria Hall |
Publisher | |
Pages | |
Release | 2020-12-04 |
Genre | |
ISBN | 9781947493551 |
FDA Regulatory Affairs
Title | FDA Regulatory Affairs PDF eBook |
Author | David Mantus |
Publisher | CRC Press |
Pages | 402 |
Release | 2014-02-28 |
Genre | 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.
Intelligence Community Legal Reference Book
Title | Intelligence Community Legal Reference Book PDF eBook |
Author | |
Publisher | |
Pages | 944 |
Release | 2012 |
Genre | Electronic surveillance |
ISBN |
Going by the Book
Title | Going by the Book PDF eBook |
Author | |
Publisher | Transaction Publishers |
Pages | 418 |
Release | |
Genre | Political Science |
ISBN | 1412824710 |
The extent to which government should be involved with regulation in the private sector is much debated. More fundamentally, one might ask exactly what is regulation, why is it needed, how is it formulated, and how is it enforced? These questions are especially relevant at a time in United States history when federal involvement in spheres traditionally left to individuals is being widely debated on all sides of the political spectrum.