New Drug Approval Process - Clinical and Regulatory Management
By Richard A. Guarino
ISBN 824773829
The New Drug Approval Process supplies readers with the global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.
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.
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