New draft guidance under White House review could reveal how far FDA hopes to go in waiving comparative efficacy trial requirements for certain biosimilars -- a policy shift FDA officials reportedly hinted at in remarks at a Global Bio Conference in Seoul last month.
Unless CMS issues additional guidance this afternoon, Medicare Administrative Contractors (MACs) may start rejecting a small amount of Medicare telehealth claims as soon as Wednesday (Oct. 15) because it marks the end of a previously announced 10-business-day claims hold.
Dozens of Republican senators are urging FDA to designate mifepristone an “imminent hazard” to public health and therefore suspend the distribution of the abortion drug that is often prescribed via telehealth, but regulatory experts say the medication doesn’t meet the qualifications for the designation.
The Centers for Disease Control and Prevention published a document outlining its strategic and policy priorities -- echoing the Trump administration’s anti-DEI and abortion and its “gold standard science” policies, and promising new research on autism and vaccination -- days ahead of this past weekend’s administration move to lay off hundreds of additional CDC employees amid the government shutdown.
A day before Friday’s reduction in force that reportedly affected hundreds of CDC employees, two key public health experts issued a warning about the public’s declining trust in the Centers for Disease Control and Prevention, warning in a commentary the polarization on whether CDC guidance can be trusted could take “a generation or more” to fix.
After the Trump administration reportedly reversed some of the massive CDC reductions in force it imposed Friday (Oct. 10), public health stakeholders are calling on Congress to ensure that the RIFs are fully reversed as part of any deal to reopen the government and that eventual fiscal 2026 funding levels do not hinder the Centers for Disease Control and Prevention’s mission.
An initial court hearing is set for Wednesday (Oct. 15) in federal worker unions’ lawsuit against the Trump administration’s massive new reductions in force Friday that predominately hit HHS and reportedly gutted CDC’s Washington presence -- RIFs that experts say if allowed to stand will further cripple what was the world’s premier public health agency.
AstraZeneca became the second drugmaker to partner with the Trump administration to sell chronic disease medications directly to patients at discounts of up to 80% through the TrumpRx website, while also securing a three-year exemption from Section 232 tariffs in exchange for onshoring its U.S. manufacturing.
HHS laid off 1,100-1,200 additional employees in Friday’s reduction in force provoked by the government shutdown, the Department of Justice said in a court filing Friday evening (Oct. 10).
