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As FDA turns its attention to rare disease treatments, including revisiting controversial decisions from former leaders on gene therapy approvals, newly tapped Center for Drug Evaluation and Research ...

FDA on Monday (Sept. 21) issued a direct final rule removing refences to animal testing from its human drug and biological product regulations, capping a yearslong effort to bring the agency into ...

Health care advocates are blasting the Trump administration’s cancellation of Affordable Care Act coverage for 750,000 people, and other stakeholders are questioning the timing and impact of the ...

The Vaccine Integrity Project founded in response to changes to HHS vaccine policy will conduct independent systemic reviews of the evidence on meningococcal and pneumococcal vaccination of children ...

The CMS Innovation Center (CMMI) should create and test a model that would help individuals approaching Medicare eligibility to make better-informed decisions about their coverage, the American ...

Vaccines advocates and experts are urging HHS not to expand the use of shared clinical decision-making for vaccines.

FDA’s Prescription Drug Use Related Software (PDURS) guidance last week advanced to the White House Office of Management and Budget (OMB) for review, drawing praise in a LinkedIn post from the ...

CMS' latest guidance on determining a medically frail exemption from Medicaid work requirements may offer administrative relief to some stakeholders, but behavioral health advocates now worry that ...

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Health care for women during and after menopause was in the spotlight this week with a Senate Special Committee on Aging hearing on the topic and an FDA workshop on testosterone therapy, which is ...

The final 2027 hospital outpatient pay rule is now under review by the White House Office of Management and Budget, as is the final rule governing Medicare pay for end-stage renal disease (ESRD).