It’s official. After a weekend of rumors and speculation, President-elect Joe Biden formally announced the nomination of California Attorney General Xavier Becerra Dec. 7 as secretary of the U.S. Department of Health and Human Services, along with Vivek Murthy as surgeon general.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FMCSA declines to allow ICD patients a commercial license; Pandemic not the time for trade restrictions.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA lists entities recognized under ASCA program.
The Pharmaceutical Research and Manufacturers Association (PhRMA) filed suit Nov. 23 in U.S. district court challenging the Trump administration’s final rule allowing the import of prescription drugs from Canada.
Two U.S. federal agencies at the Department of Health and Human Services (HHS) have finalized rules that affect how drug and device makers interact with the health care system, but under the Congressional Review Act, neither rule can go into effect until February 2021. This timeline comes up a couple of weeks after President-elect Joseph Biden is sworn in, thus raising the risk that the new administration at HHS will either modify or overturn these rules altogether.
When U.S. President Donald Trump and Health and Human Services (HHS) Secretary Alex Azar announced last week the Jan. 1 launch of a Medicare Part B most-favored nation (MFN) drug pricing model and a final rule to end Medicare’s safe harbor for the rebates that create a black box around the pricing of Part D drugs, they called the reforms “historic.”
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: WHO targets cervical cancer; More time to comment on instituting PTAB trials.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS plans retrospective regulatory review.
