The Pharmaceutical Regulatory Process |
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| Editor:
| Berry, Ira R.
Martin, Robert P. |
| Series title: | Drugs and the Pharmaceutical Sciences Ser. |
| ISBN: | 978-1-4200-7042-2 |
| Publication Date: | Dec 2008 |
| Publisher: | CRC Press LLC
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| Book Format: | Hardback |
| List Price: | USD $220.00 |
Book Description:
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This Second Editionexamines 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....
More DescriptionThis Second Editionexamines 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.
New chapters cover: