The Pharmaceutical Regulatory Process

The Pharmaceutical Regulatory Process

The Pharmaceutical Regulatory Process

The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P. Martin, Drugs and the Pharmaceutical Sciences,Vol. 185. Informa Health care Publishers.

The Pharmaceutical Regulatory Process

R. Berry Ira, Robert P. Martin

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.

Categories:

Medicine

Year:

2008

Edition:

2

Publisher:

Informa Healthcare

Language:

English

Pages:

492

ISBN 10:

1420070428

ISBN 13:

9781420070422

Series:

Drugs and the Pharmaceutical Sciences

File:

PDF, 4.03 MB

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