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FDA Issues New Rules for Pediatric Drug Trials

FDA issued two new guidances on development and clinical trials of pediatric medications replacing 2005 rules. Pediatric drugs are developed slower difficulty clinical testing. Adult drugs can be used off label for children. New rules incentivize pediatric drug development. ....

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MSNBC Way Too Early September 27, 2021 09:49:00

Increase transparency, and make sure america comes along with conditions that have confidence. there also seems to be wide leeway under what americans might qualify to get that booster. doctor, one more for you just now. pfizer is saying they think they could be on track for asking for emergency use authorization for their children, 5 through 11, maybe in a matter of days. this would be an extraordinary step, a relief to a lot of parents. when they starts happening, what you do think that will do to change the face of the pandemic here in the united states? it s critically important. look, we thought we were going to get this data over the summer, and fda went back and asked pfizer to do a much larger pediatric study. now we re doubly assured of the safety of these pediatric doses. we ve seen pediatric cases increase. ....

Increase Transparency , Emergency Use Authorization , Pediatric Study ,

For children with classic congenital adrenal hyperplasia, researchers are working to advance treatment options

For children with classic congenital adrenal hyperplasia, researchers are working to advance treatment options
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