Jessica Adams
@RxRegA
Interests-scientific integrity, data standards, transparency, FDA.20y+ background in reg affairs,10+ covering adcomms @FDAadcomms,Former FDA,IQVIA,Genentech,AZ
If you're interested in FDA advisory committees (adcomms) please check out my other account @FDAadcomms. There I track upcoming adcomm meeting dates and topics. I also share the outcomes of meetings and other relevant info. Not to mention, I'm also paying attention to planned…
$SRPT CHMP recommends against Sarepta's Elevidys ema.europa.eu/en/medicines/h…
It's going to be a challenge for me to g from having statistical hierarchy hammered into my brain for 9 years through countless pages of FDA advisory committees briefing and through hearing the phrase "hypothesis-generating" repeated often at meetings to accepting approvals…
My insomnia-driven posts always seem like the best in the moment. Not always in the morning.
Can anyone send me the articles on Sarepta from Endpoints today? 🙏🏻 DM's open
I woke up this morning fine with letting the FDA take what time it needs to evaluate the Sarepta situation. I'm going to bed needing to know what TF is going on ASAP.
How did it go from never returning to being back on with a 10 to 12 patient safety study in a few hours? Did you ask this? I don't have access and I wish I did.
Exclusive: $SRPT would have to conduct new studies to get back on market, FDA official says - CBER review staff are 'unanimous' that Elevidys should never return to market endpoints.news/sarepta-would-…
Spent way too much time today fruitlessly trying to reconcile TF is going on with Sarepta from media reports
Did not know this
.@RxRegA Technically under federal law a senior employee is anyone at GS-15 or above. That would make almost every MD a senior employee As well as a lot of other people including both the clinical pharmacology division directors and associate division directors.