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The Greatest FDA Advisory Committees, Part II: The Birth Of The ‘Pazdur Moment’

With landmark advisory committee meetings coming up, we take a look back at some of the memorable panel meetings over the last 20 years. This is Part II in the series.

Advisory Committees Leadership

Hurry Up and Wait: The Slowdown in Accelerated Approvals

Accelerated approvals are decelerating. Sponsors argue the FDA is so caught up in the current emphasis on safety that they're raising the AA efficacy standards. The FDA contends that the companies who have been rejected aren't meeting the efficacy standards or performing the promised follow-up trials. Is the FDA changing the rules-or are companies themselves bending them? A look at several recent cases of AA therapies reveals that both are true.

BioPharmaceutical Clinical Trials

Drug Approvals of 2004

We review new drugs approved by the FDA in 2004, and the ratio of those developed internally to those that were in-licensed.


Schering: Addressing the Specialist Challenge

As a large yet specialist firm, Schering must compete in multiple areas. That means developing and marketing differentiated products across a number of fronts--and dealing with the lower-than-average margins that typically come with mixed portfolios. How well the German group overcomes these challenges should be of growing interest to Big Pharma, given the risks of relying on blockbusters.

BioPharmaceutical Strategy
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