HHS' Office of Inspector General plans to investigate how 503B outsourcing facilities and hospitals produce and use compounded sterile drugs and how many of them voluntarily register with FDA.

Two former GOP health care lawmakers are warning the White House that rising infectious disease rates coupled with the administration’s mixed messaging on vaccines are a “self-inflicted wound” that ...

Health policy stakeholders and former FDA officials are backing a group of bipartisan drug development reforms they say could boost domestic clinical research and expand patient access to treatments, ...

A new group of hospitals is rallying for the United States District Court for the District of Maine to once again block the government from implementing a pilot program that will replace upfront ...

FDA has formally asked the White House Office of Management and Budget (OMB) to approve an “interim access policy” that could create a temporary pathway for state-licensed pharmacies to compound ...

FDA on Wednesday (Oct. 14) launched a Rare Disease Framework Initiative that it says will reform the development of rare disease treatments by considering each disease’s specific patient population ...

FDA published long-awaited final guidance Monday (Oct. 19) laying out what identity and safety information manufacturers and distributors should include in a new dietary ingredient notification (NDIN) ...

The lobby representing agents and brokers has asked a federal court to block the administration’s move to slap a moratorium on new agents/brokers ahead of the 2027 Affordable Care Act open enrollment ...

A bipartisan group of 22 state attorneys general is filing a notice in bankruptcy proceedings for Character Technologies, Inc., the firm behind the chatbot company Character.AI that presented AI ...

HHS’ planning office is backing major cuts to hospitals’ 340B reimbursement rates, arguing lower payments would better reflect acquisition costs and discourage hospitals from profiting from the ...

The Centers for Disease Control and Prevention is preparing to provide additional assistant to Pennsylvania in its ongoing measles outbreak as cases continue to mount, but Pennsylvania’s Department of ...

The U.S. Solicitor General is seeking permission from the Supreme Court to present an amicus curiae argument during oral arguments in an upcoming case on transgender care for minors, amid the Trump ...