Companion on Drug Regulatory Submissions : Companion on Drug Regulatory Submissions
$8.13
Sale price
$8.13
Regular price
$8.13
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Companion on Drug Regulatory Submissions : Companion on Drug Regulatory Submissions
$8.13
Sale price
$8.13
Regular price
$8.13
Sold by Ergodemedia, an authorized reseller of Authentic New & Used Books with Free US Shipping.
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Description
A formal submission to the United States Food and Drug Administration is a professionally frightening proposition. There is a great deal at stake: the submission can lead to permission to move forward with a drug development project, with the promise of patient improvement and corporate profits. Thesubmission represents the tightest of bottlenecks in that development process: delays affect every other part of the operation, leading to criticism from clinicalmedical; chemistry, manufacturing, and control testing ; and all other departments. And the submission response itself is open, with blunt comments from a heartless agency widely distributed. Many a regulatory professional has lost sleep over the prospect of a major submission.
Product Notice
This book is sold in used condition unless explicitly stated as new.
Condition is graded and described accurately. Some books may contain
previous owner's markings, highlights, or inscriptions. This product
may contain chemicals known to the State of California to cause cancer
or reproductive harm. For more information visit
www.P65Warnings.ca.gov
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