عنوان

FDA regulatory affairs :

1420073540 (hbk. : alk. paper)

9781420073546 (hbk. : alk. paper)

dltt

FDA regulatory affairs :

[Book]

a guide for prescription drugs, medical devices, and biologics /

edited by Douglas J. Pisano, David S. Mantus

2nd ed

New York :

Informa Healthcare USA,

c2008

viii, 448 p. :

ill. ;

24 cm

Includes bibliographical references and index

Overview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- What is an IND / Charles Monahan and Josephine C. Babiarz -- Meeting with the FDA / Alberto Grignolo -- FDA medical device regulation / Barry Sall -- The development of orphan drugs / Tan T. Nguyen -- CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- Electronic submissions--a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vahé Ghahraman -- The practice of regulatory affairs / David S. Mantus -- A primer of drug/device law : what's the law and how do I find it / Josephine C. Babiarz -- FDA advisory committees / Christina A. McCarthy and David S. Mantus -- Biologics / Timothy A. Keutzer

0

United States.

United States.

Drug development-- United States

Pharmaceutical industry-- United States

Biological Products-- standards

Drug Industry-- standards

Equipment and Supplies-- standards

Government Regulation

United States Government Agencies

United States

2

Mantus, David

Pisano, Douglas J

20160427144533.0

[Book]

Y