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RIVULET MEDIA INC. RIVU
Posted On: 09/24/2013 10:14:13 PM
Post# of 5066
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Posted By: WhyWeTrance

Shamelessly Taken from FierceBiotech
It made me think, but not long Hehehe

So what happens at the  FDA in the event of a government shutdown next Tuesday? For now, the agency isn't saying, referring reporters to an OMB statement guiding government agencies to prepare to execute "an orderly shutdown."


But the FDA has been here before and agency watchers are referring to some of the old guidelines to prepare for what may--or may not--be about to happen. For drug developers in particular, it seems clear that a government shutdown would delay PDUFA dates for any companies looking to get a near-term approval. FDA panel reviews for drugs under regulatory review are also likely to get pushed back.


A short interruption in government services would not likely have a big impact on the regulatory timelines. But all bets are off if there's a lengthy interruption, which has the potential to roil the arrival of some closely watched therapies.



Read more:  Government shutdown would likely roil FDA's drug-approval process - FierceBiotech http://www.fiercebiotech.com/story/government...z2frlyuEZU



Man o Man I'm looking forward to the sheer amount of progress in BioPharma.
Still holding a very Nice chunk of shares- long but not as strong.

Good luck to all & Go $BMSN














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