Joined March 2009
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NortheasternLaw retweeted
Says @sbagen in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: government action based on one-sided information rather than full review is concerning. Career people in FDA can be pain - because many people there work hard to go through and ask the questions.
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NortheasternLaw retweeted
Says @david__simon in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: example: Dr. Makary saw study online, said we call the manufacturers. Concerning!
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NortheasternLaw retweeted
Says @drsinhaesq in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: drugs approved close to deadline have more safety problems. Now we see this. And Dr. Makary giving bonuses to employees who skip steps in review - troubling.
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NortheasternLaw retweeted
Says @sbagen in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: we see the voucher process, which allows companies to get around FDA's procedures - waives requirements. The idea of giving someone a pass because they did something for administration - tricky.
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NortheasternLaw retweeted
Says @david__simon in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: are we seeing deals with FDA by companies, and where is the line between corruption and capture?
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NortheasternLaw retweeted
Says @rachelsachs.bsky.social in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: if you want to be able to prevent and treat diseases, you want companies to invest.
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NortheasternLaw retweeted
Says @rachelsachs in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: because drug development path is long, important that companies can trust that advice they get at point A will hold.
High turnout - companies report advice from FDA changing, moving goal posts.
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NortheasternLaw retweeted
Says @DrSinhaEsq in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: unclear Dr. Makary made good appointments. Also unclear if they answer to Makary or Kennedy.
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NortheasternLaw retweeted
Says @DrSinhaEsq in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: over decades there were great scientists with institutional knowledge and expertise. When Makary appointed 3000 fired - position to make appointments, and they were political.
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NortheasternLaw retweeted
Says @sbagen in the panel on the FDA regulatory environment in #HLC2026 in @NUSL: mattered: FDA exists so people can trust the drugs they take and food they eat, and if they can't trust the decisions are based on evidence and good process - bad for FDA legitimacy, and products.
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NortheasternLaw retweeted
Says @sbagen, leading the panel on the FDA regulatory environment in #HLC2026 in @NUSL: norm strong, do not want to overstate it- or overstate line between policy and product approval - but norms were strong (in background, administration excepts political loyalty from everyone).
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NortheasternLaw retweeted
Says @rachel_sachs, leading the panel on the FDA regulatory environment in #HLC2026 in @NUSL: different from policy decisions, where administrations dictate. More comfort of political appointees in this administration to intervene in those.
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NortheasternLaw retweeted
Says @rachel_sachs, leading the panel on the FDA regulatory environment in #HLC2026 in @NUSL: we often think of FDA as independent of direct politics - norm that political appointees don't intervene in specific product decision. Usually respected across administrations.
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NortheasternLaw retweeted
Says @david__simon, leading the panel on the FDA regulatory environment in #HLC2026 in @NUSL: Kennedy wants to bring in peptides. Concerning politicization in FDA. Question: how unusual is it for politics to play a role in the FDA?
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