FDA Regulatory Affairs: Third Edition - Image 1

£43.99

CRC Press FDA Regulatory Affairs: Third Edition

Name: FDA Regulatory Affairs: Third Edition
Brand: CRC Press
Price: 43.99 GBP
Availability: InStock

Pharmacy

It has never been this cheap. We have no record of a lower price.

£44 today · cheaper than every other day in the last 3 months

NEW HERE?

Amazon shows you one price. We show you all of them.

Tosheroon watches Amazon prices so you don't have to. Every product on Amazon has a price history — we make it visible. Set the price you'd actually pay, and we'll email you the second it gets there. No app, no account, one email.

WHAT'S ON THIS PAGE

↓ Price chart
when this has been cheap or pricey

↓ Forecast
where the price is heading next

↓ Statistics
all-time high & low, recent range

↑ Price alert
name your number, we'll email you

Price History & Forecast

Grey patches = out of stock. Cheaper = lower on the chart. Hover for exact prices.

Last 69 days · 69 data points (no recent data)

Historical

Generating forecast…

Price Distribution

Price distribution over 69 days • 2 price levels

Days at Price

Current Price

Price Analysis

Most common price: £46 (46 days, 66.7%)

Price range: £44 - £46

Price levels: 2 different prices over 69 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 > Science, Nature & Maths > Medicine > Pharmacy
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

It has never been this cheap. We have no record of a lower price.

Price History & Forecast

Price Distribution

Price Analysis

Description

Product Specifications

Barcode

Similar Products You Might Like

Regulatory Affairs in the Pharmaceutical Industry

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

Guide to EU and UK Pharmaceutical Regulatory Law

Regulatory Protection in the Pharmaceutical and Life Science Industries: Challenges, Opportunities and Ongoing Reform (Elgar Monographs in Intellectual Property Law)

Navigating FDA Drug Approval: A Comprehensive Guide to Application Success

Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

Food and Drug Law and Regulation

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

FDA's Drug Review Process and the Package Label: Strategies for Writing Successful FDA Submissions

Specification of Drug Substances and Products: Development and Validation of Analytical Methods

Mastering and Managing the FDA Maze: Medical Device Overview

Medical Writing in Drug Development: A Practical Guide for Pharmaceutical Research

Statistics In the Pharmaceutical Industry: 14 (Chapman & Hall/CRC Biostatistics Series)

Das europäische Arzneimittelrecht: Zentrale Rechtsfragen des Arzneimittelzulassungsverfahrens

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products

Economics of the Pharmaceutical and Medical Device Industry: Supply Chain, Trade and Innovation (Routledge Studies in the Economics of Innovation)

Quality by Design for Biopharmaceutical Drug Product Development: 18 (AAPS Advances in the Pharmaceutical Sciences Series, 18)

Benefit-Risk Assessment in Pharmaceutical Research and Development (Chapman & Hall/CRC Biostatistics Series)

Write It Down: Guidance for Preparing Effective and Compliant Documentation

Write It Down: Guidance for Preparing Effective and Compliant Documentation

Pharmaceutical Medicine (Oxford Specialist Handbooks)

Theory of Drug Development: 61 (Chapman & Hall/CRC Biostatistics Series)

Biosimilars and Interchangeable Biologics: Strategic Elements