FDA Regulatory Affairs: Third Edition - Image 1

£42.31

CRC Press FDA Regulatory Affairs: Third Edition

Name: FDA Regulatory Affairs: Third Edition
Brand: CRC Press
Price: 42.31 GBP
Availability: InStock

Law

Price History & Forecast

Last 26 days • 26 data points (No recent data available)

Historical

Generating forecast...

Price Distribution

Price distribution over 26 days • 1 price levels

Days at Price

Price Analysis

Most common price: £42 (26 days, 100.0%)

Price range: £42 - £42

Price levels: 1 different prices over 26 days

Description

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.

Product Specifications

Brand: CRC Press
Format: paperback
ASIN: 1032920548
Category: Books > Subjects > Business, Finance & Law > Law
Domain: Amazon UK
Release Date: 14 October 2024
Listed Since: 09 August 2024

Barcode

No barcode data available

CRC Press FDA Regulatory Affairs: Third Edition

Price History & Forecast

Price Distribution

Price Analysis

Description

Product Specifications

Barcode

Similar Products You Might Like

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco

Regulatory Affairs in the Pharmaceutical Industry

Pharmaceutical Dosage Forms - Parenteral Medications: Volume 3: Regulations, Validation and the Future

Pharmaceutical Dosage Forms: Parenteral Medications: 003

Food and Drug Law and Regulation

Medical Device Regulation: FDA-CDRH Manufacturing, Policies and Regulation Handbook

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

Mastering and Managing the FDA Maze: Medical Device Overview

Computer System Validation: Pharmaceutical, Biologics, and Medical Device Regulations, Concise Reference

Filtration and Purification in the Biopharmaceutical Industry, Third Edition (Drugs and the Pharmaceutical Sciences)

Pharmaceutical Product Development: Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Three, Liquid Products: 3

Medical Affairs: The Roles, Value and Practice of Medical Affairs in the Biopharmaceutical and Medical Technology Industries

Filtration and Purification in the Biopharmaceutical Industry, Third Edition (Drugs and the Pharmaceutical Sciences)

Development and Evaluation of Drugs: From Laboratory through Licensure to Market

Contract Research and Development Organizations-Their History, Selection, and Utilization

Development of Biopharmaceutical Drug-Device Products: 35 (AAPS Advances in the Pharmaceutical Sciences Series, 35)

Drug Discovery and Development, Third Edition

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

Medical Affairs: The Roles, Value and Practice of Medical Affairs in the Biopharmaceutical and Medical Technology Industries

Biosimilars Development Strategies: Fast to Market Approaches

CRC Press Preparing for FDA Pre-Approval Inspections 2nd Ed