Can Courts And States Override FDA’s Drug Regulatory Authority?
Dueling suits seek to force US FDA to withdraw approval of mifepristone or prevent it from doing so while legislation introduced in Idaho would outlaw the use of mRNA technology. Lawyers say these are worrisome challenges to the agency's scientific judgement.
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With COVID Crash In Sight, Moderna’s Post-Pandemic Future Starts To Take Shape
The company reported a fourth quarter decline in SARS-CoV-2 vaccine sales and guided for sales of $5bn in 2023. It is looking ahead to filing for approval of its RSV vaccine.
Order For Withdrawal Of Mifepristone Would Be ‘Unprecedented,’ Seismic Event; Wyden Says FDA Must Ignore It
Senator Wyden says the case has been "a rigged game all along" as state attorneys general and medical groups file briefs in the suit against the FDA.
Mifepristone REMS For Pharmacies Contains Some Unusual Provisions, Continues Debate Over Access
After FDA clears modified REMS, certified retail pharmacists are permitted to dispense the abortion medication. Some advocates argue program is unnecessary, while others want a broader federal effort to expand access. Walgreens intends to become a certified pharmacy.