Apparently, in an echo of the split (6-4) ODAC vote, on October 5, 2009 we earlier reported -- the FDA has declined to immediately approve this new indication for Merck/Schering-Plough's PegIntron®. Instead, FDA staff sent Schering-Plough a complete response letter -- essentially, a "regulatory punch-list" of open items, before approval may be granted. Per Reuters' reporting:
. . . .The company is seeking FDA permission to sell the injectable drug for melanoma. But the agency declined to approve the new use, at least right now, instead issuing a complete response letter about remaining issues.
"Schering-Plough will work closely with FDA to respond to outstanding concerns related to the PegIntron melanoma filing," the company said in a statement.
Schering did not say what the FDA's concerns were and company spokeswoman Mary-Francis Faraji said the drugmaker had no additional comment. . . .
Ouch.
5 comments:
You need think about it. Despite the emails, the overwhelming evidence showing global warming is happening hasn't changed.
"The e-mails do nothing to undermine the very strong scientific consensus . . . that tells us the Earth is warming, that warming is largely a result of human activity," Jane Lubchenco, who heads the National Oceanic and Atmospheric Administration, told a House committee. She said that the e-mails don't cover data from NOAA and NASA, whose independent climate records show dramatic warming.
What you think about news - GOPers Hold 'Prayercast' to Ask God to Stop Health Reform ?
Wanna hear your opinion
Как вы относитесь к непопулярным статьям в блогах
Как вы относитесь к непопулярным статьям в блогах
hi, spring is cooming! good post there, tnx for www.blogger.com
Post a Comment