Remarkable move by Dr Peter Marks of FDA, and excellent explanation of rationale and longer-term oversight strategy for #accelerated#approval for cutting-edge #cellandgenetherapy for #patients with incurable conditions and no viable #treatment options.…https://t.co/P286KaFyGt
🚨@ISSCR files amicus brief joined by @ISCTglobal supporting #FDA. Critical that FDA be permitted to use its scientific and medical expertise to evaluate efficacy of products, manage risk of products intended for consumers, & take appropriate enforcement actions to protect the public from dangerous products. #stemcell #regulatory #bioethics
Less then a week until #ISCT2023 Paris!
So honored to chairing "Mapping the Landscape of Public and Patient Access & Engagement" concurrent session on June 2, with Aaron Levine, Finn Willingham, and Leigh Turner, discussing critical #ethical & #societa…https://t.co/MQgl6lTtU5
As a Health Policy Analyst and Bioethicist, I am *very* glad #DEA decided to delay and potentially re-consider its highly-restrictive proposed #telemedicine#prescribing rules for a wide range of #controlled substances - incl. for…https://t.co/bMoJhdK12P https://t.co/JzRuCC5sSz
Interesting trend in #legislation to foreclose or increase difficulty of #lawsuits against #agencies (in rather stark contrast to the current #litigation landscape), particularly against #HHS . S. 1067 (to Ensure Timely Access to #genericdrugs) makes #Cit…https://t.co/K6BW3WSe4S
BREAKING: Walgreens confirmed to @politico that they will not dispense abortion pills in several states where they remain legal. The decision follows pressure and threats of legal action from GOP AGs and anti-abortion groups.
https://t.co/KCeLPnGs1G
To analyze the potential impact of @FTC's settlement with GoodRx on the digital health ecosystem, I spoke with legal and privacy experts: https://t.co/VvPzjWCNeg @BRoxBioethics@DCRINews
To analyze the potential impact of @FTC's settlement with GoodRx on the digital health ecosystem, I spoke with legal and privacy experts: https://t.co/VvPzjWCNeg @BRoxBioethics@DCRINews
QUOTED! Great coverage of the #FTC's rather stunning allegations against #GoodRx of violations under the #Health#Breach#Notification Rule & the #Federal Trade Commission Act for sharing sensitive, identifiable #healthdata with 3r…https://t.co/ST234M617G https://t.co/G8rGLEuxmQ
AMAZING NEWS. New drug approved based on uncontrolled study, so we will never know how to optimally use it! Congrats to the investigators who figured out you don't need a control arm, and especially FDA for setting the bar so low we can trip over it!
FDA (finally!) appeals its loss in big unproven stem cell clinic case -- Cell Surgical Network lawsuit -- here in CA. What's going on? https://t.co/x4PAtVtKbD