FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics /
Saved in:
| Online Access: |
Publisher description |
|---|---|
| Other Authors: | , |
| Format: | Book |
| Language: | English |
| Published: |
New York :
Informa Healthcare USA,
2008
|
| Edition: | 2nd ed. |
| Subjects: |
Table of Contents:
- 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 Vahâe 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.
