Pandemic flu: Federal preparations for and response to the H1N1 flu outbreak is funded with $7.7 billion in the 2009 supplemental appropriations bill approved by House and Senate conferees June 11. The funds are allotted to HHS, but most - $5.8 billion - will be available only on a contingency basis for critical needs. The remaining $1.85 billion, the amount provided by the original House bill and $350 million more than by the Senate bill, will be immediately available. Bill language has not been released yet, but a House staffer said the money will be divvied up according to earlier House language, which allowed financing of private vaccine production facility construction or rehabilitation (1"The Pink Sheet," May 25, 2009, p. 32). The White House requested the contingency funds June 2; final House and Senate approval on the consensus measure is expected shortly. The agreement came the same day as the World Health Organization announced that the spread of the H1N1 virus meets criteria for an influenza pandemic
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
