The Patient-Centered Outcomes Research Institute announces plans to encourage the submission of more proposals for head-to-head clinical comparative effectiveness studies. Among the research topics the institute will encourage are the Institute of Medicine’s top 100 priorities and recommendations from America’s Health Insurance Plans.
The Patient-Centered Outcomes Research Institute is taking action to boost the number of head-to-head comparative effectiveness trials it funds after a review of applications selected for funding during its first three cycles found a relatively low number of direct head-to-head comparisons.
“It’s pretty clear that PCORI needs to do something to increase in its portfolio the numbers of genuine primary comparative...
The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.
The new Advisory Committee on Immunization Practices members endorsed Merck & Co.’s monoclonal antibody for RSV prevention, but some questioned its use in healthy babies and potential interactions with vaccines given at the same time.
CMS Administrator Mehmet Oz said PBMs may deserve "one last chance" to fix the rebate system before federal regulations and legislation are enacted.
The list of essential prescription drugs and related products will shape Canada’s first national formulary for the country’s universal pharmacare program.
