And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still getting sorted out, but we hope to catch up on our reading and hang with our oh-so-busy short person. And what about you? Normally, we would suggest you enjoy the great outdoors, but given the heat, we hesitate to do so, unless you have a Jetsons-like portable air conditioner you can strap on your back. With that in mind, this may be an opportunity to enjoy a flick or two on the telly, meet a fun friend at a whiskey bar, or simply take a few naps. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
The European Medicines Agency has recommended a vaccine made by Bavarian Nordic for protection against monkeypox, Reuters writes. The vaccine, which is the only one to have won approval for preventing monkeypox disease in the U.S. and Canada, has in the European Union so far only been approved to treat smallpox. But the company has supplied the vaccine to several EU countries during the current monkeypox outbreak for “off-label” use. The recommendation from the EMA is expected to be referred to the European Commission for final approval shortly.
With just over two months to go, it appears increasingly likely that Congress is going to miss its deadlines to pass a final U.S. Food and Drug Administration appropriations bill and a user-fee reauthorization bill, Regulatory Focus tells us. On June 20, Democrats in the U.S. House passed a $400 billion “minibus” appropriations bill in a 220-207 vote that largely split down party lines. So now, it is up to the U.S. Senate to pass a similar bill, but lawmakers in the upper chamber have yet to even publicly present their budget bill, with a Sept. 30 deadline quickly approaching. The House bill includes a $341 million increase over last year’s budget for the FDA.
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