Report: Outsourcing of Regulatory Services Rising Dramatically

Posted 11 May 2012 | By

A new report out from the Tufts Center for the Study of Drug Development (TCSDD) has found the rate at which pharmaceutical companies are outsourcing their regulatory affairs services has risen dramatically in the past five years.

"Spending on outsources regulatory services by developers rose 167% between 2007 and 2010," says TCSDD in its report, which focused on the experience of pharmaceutical manufacturers during the fourth iteration of the Prescription Drug User Fee Act. The study looked at "eight top companies, which led to the development of pilot studies that provided data for the analyses."

The report also highlighted a number of regulatory-based conclusions, including:

Since 2007, the regulatory burden decreased for new drug applications (NDA) and biologics license applications (BLA) approvals, but increased for supplemental new drug applications (sNDA) and biologics license approvals (sBLA).

Ten of 21 regulatory activity variables were considered significant by sponsors, when optimal and sub-optimal approvals were compared on a disparity index.

Read more:

TCSDD - Drug Sponsors' Regulatory Experience Was Mixed During PDUFA IV


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