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Off-Label Promoter In Chief: President Trump Pushes COVID-19 Therapy

 
• By Michael McCaughan

If the President says over and over again that a drug is approved, does that make it so?

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The President of the United States has the ability to de-classify anything he chooses – no matter who in the national security bureaucracy may disagree.

He also has the authority to pardon anyone (perhaps even including himself) – no matter what federal

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Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

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New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
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At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.

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EU Shaping Biotech Act To Unleash SME Potential

 
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European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 
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‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.