Posted On: 04/06/2016 8:41:09 PM
Post# of 72446
http://www.pewtrusts.org/en/research-and-anal...infections
Q: What is the difference between LPAD approval and Accelerated Approval?
A: There are several key differences between LPAD and FDA’s existing Accelerated Approval program.
LPAD approvals would be full and final approvals, not contingent on additional follow-up studies the way Accelerated Approvals are. LPAD is not an expedited development program.
Unlike Accelerated Approval, or any of FDA’s other existing expedited programs, LPAD offers approvals limited to specific populations of patients with unmet medical needs.
LPAD would be the only approval mechanism to utilize mandatory additional measures (outlined below) to help ensure that drugs approved through the pathway are used appropriately.
Q: What is the difference between LPAD approval and Accelerated Approval?
A: There are several key differences between LPAD and FDA’s existing Accelerated Approval program.
LPAD approvals would be full and final approvals, not contingent on additional follow-up studies the way Accelerated Approvals are. LPAD is not an expedited development program.
Unlike Accelerated Approval, or any of FDA’s other existing expedited programs, LPAD offers approvals limited to specific populations of patients with unmet medical needs.
LPAD would be the only approval mechanism to utilize mandatory additional measures (outlined below) to help ensure that drugs approved through the pathway are used appropriately.
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***On 02/26/2016 at 8:33 am Scottsmith admited to posting under 5 aliases but his post was subsequently deleted. I have a screen shot and will email it to anyone interested.
