Home : Book details

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, 2nd Edition free ebook download

Category:
Medicine

Views: 129
Likes: 166

Catalogue

Author(s):	Douglas J. Pisano, David S. Mantus

Date:	2008	Format:	PDF	Language:	English	ISBN/ASIN:	1420073540
Pages:	1	OCR:		Quality:		ISBN13:
Uploader:	topron	Upload Date:	3/23/2020 12:35:26 AM

To download click on link in the Links Table below

Description: Click to see full description

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

FDA Regulatory Affairs:

provides a blueprint to the FDA and drug, biologic, and medical device development
offers current, real-time information in a simple and concise format
contains a chapter highlighting the new drug application (NDA) process
discusses FDA inspection processes and enforcement options
includes contributions from experts at companies such as Millennium and Genzyme, leading CROs such as PAREXEL and the Biologics Consulting Group, and the FDA

Three all-new chapters cover:

clinical trial exemptions
advisory committees
provisions for fast track

Links Table

	Title	Link	Password	Size (MB)	Thank to	Inform Admin
2731482	Book	https://tezfiles.com/file/d4af82e473082...		8.00	topron

Tags: Affairs Biologics Devices Drugs Guide Medical Prescription Regulatory

Title	Link	Password	Size	Reason

Those who downloaded this book also downloaded the following books:

Comments

New comment:

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, 2nd Edition free ebook download

Category: Medicine

Description: Click to see full description

Category:
Medicine