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BioWorld - Friday, January 30, 2026
Home » HHS

Articles Tagged with ''HHS''

Regulatory front for April 9, 2021

April 9, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS, DOJ officials highlight pandemic response needs; FDA says plenty of respirators available; NICE supports use of Danis for variceal hemorrhage.
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Regulatory front for March 25, 2021

March 25, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA seeks nominations for blood products advisory panel; Massachusetts hospital hit for HIPAA access non-compliance; No reports recorded for Medtronic recall; Tillis, Cotton eye patent examiner practice for Section 101 problem.
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Regulatory front for March 19, 2021

March 19, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: SUNSET rule suspended; Alliance calls for speedy nomination of FDA commissioner; Pandemic costly to TB effort; FDA announces May 4 patient data meeting.
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U.S. FDA headquarters

Is U.S. FDA getting tougher under Biden?

March 18, 2021
By Mari Serebrov
Although U.S. President Joe Biden has yet to nominate his choice to lead the FDA, his nomination of Xavier Becerra as the next Health and Human Services (HHS) secretary – and Becerra’s Senate confirmation March 18 – could signal a shift to a more conservative approach at the FDA when it comes to approving new drugs and devices.
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Regulatory front for March 11, 2021

March 11, 2021
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIH touts new polygenic risk score methodology; HHS extends comment period for HIPAA NPRM.
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U.S. flag, stethoscope

MCIT program not seen as being at risk under Becerra at HHS

March 8, 2021
By Mark McCarty
The Biden administration imposed a regulatory freeze in January, which among other things affected the final rule for the Medicare Coverage of Innovative Technologies (MCIT) program. Despite the freeze, Cybil Roehrenbeck, a partner in the D.C. office of Hogan Lovells US LLP, told BioWorld that this program enjoys broad support in Washington, and thus should survive the new administration’s review of the program under Xavier Becerra, should he be appointed the Secretary of Health and Human Services.
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US flag, Department of Health and Human Services flags

U.S. Senate committee renders tie vote on Becerra to run HHS

March 3, 2021
By Mark McCarty
The U.S. Senate Finance Committee hearing for the appointment of Xavier Becerra as Secretary of Health and Human Services ended in a tie vote, which not unexpectedly ran along party lines. The nomination of Becerra was controversial on several fronts, but the outcome nonetheless sends the nomination to the Senate floor, where Vice President Kamala Harris may cast the deciding vote in what is likely to be a literal 50-50 deadlock.
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Xavier Becerra, HHS secretary nominee

Price transparency emphasized in Becerra’s first Senate hearing for HHS job

Feb. 23, 2021
By Mark McCarty
The first Senate hearing for the nomination of Xavier Becerra as Secretary of Health and Human Services included the predictable questions about his qualifications, given his position as attorney general for the state of California. However, the candidate repeatedly emphasized price transparency for both hospitals and drug manufacturers, the latter of which are still laboring under the perception that price gouging is a common practice.
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Regulatory front for Feb. 17, 2021

Feb. 17, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS commits more funds for testing, materials to fight pandemic; Medtronic announces recall of Valiant Navion; Florida man pleads guilty in DME fraud.
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Regulatory front for Feb. 12, 2021

Feb. 12, 2021
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA cites pivotal study failure for Lutonix 014; HHS adds to PREP Act immunity; Dermal fillers on tap at FDA advisory; GAO urges a pause in VA EHR deployment.
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