2010

Survey: relationship between FDA and life sciences industry deteriorating, delays in review process cited

Monday, December 13, 2010

Top biopharmaceutical company executives are frustrated with delays and inconsistencies in the Food and Drug Administration (FDA) regulatory review process and are concerned that passage of the healthcare reform law, which gave the already resource-constrained agency more responsibilities, will further complicate drug approvals, according to a new PricewaterhouseCoopers (PwC) survey.

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FDA: Generic transdermal patches should be tested in divergent climates

Monday, November 22, 2010

A patch that delivers medicine transdermally may act very differently on a resident of Fargo, N.D., than on someone in South Florida. Thus, the amount of medicine that enters their bloodstreams may be different. That’s the assertion of the FDA’s Office of Generic Drugs, and that’s why the regulatory body now asks that drug developers working on transdermal patches—at least in the generics realm—test their patches in multiple divergent climates.

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