hhs-innovation 
Nixon Gwilt Law
APRIL 22, 2024
new laws and regulations), we can draw inferences about what to expect using our experience navigating other innovative policy rollouts and currently published memoranda and guidance from the White House, federal and state agencies, and broad industry coalitions. While industry awaits formal legislative and agency action (e.g.,
Legacy MEDSearch
JULY 28, 2023
Department of Health and Human Services (HHS). “Completing our base-stage performance milestones ahead of schedule is a testament to our organization’s dedication and commitment to healthcare innovation,” said Delphine Le Roux, PhD, PMP, Director of Program Management.
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European Pharmaceutical Review
MARCH 4, 2024
Demonstrating promising results in delivering oligonucleotides and mRNA therapeutics, LNPs likely stand as the future preferred biologic drug carriers, especially for cancer vaccines or other innovative treatments. However, the latest scientific research suggests that we are entering a new era of innovation in this field.
PM360
APRIL 7, 2023
Scott Briggs Medicare price negotiation is certainly the most oft-discussed provision of the IRA, but the extent to which the negotiated “Maximum Fair Prices” (MFP) tend to gravitate towards the statutory maximums vs. meaningfully lower prices will largely depend on HHS and CMS’ interpretation of the act’s mandate.
European Pharmaceutical Review
NOVEMBER 8, 2022
For example, the US recently passed the Inflation Reduction Act, 1 which requires the Secretary of Health and Human Services (HHS) to negotiate prices for certain physician-administered and retail prescription drugs covered under Medicare Parts B and D. Measuring and rating biosimilar access. Conclusion. 562, 117th Cong. §
Nixon Gwilt Law
SEPTEMBER 7, 2023
However, as with any emerging area of healthcare innovation, new legal and regulatory considerations arise that must be thoughtfully addressed. Department of Health & Human Services (“HHS”) requires Institutional Review Board (“IRB") approval and oversight for more categories of research involving children than those involving adults.
Nixon Gwilt Law
MAY 11, 2023
The COVID-19 Declaration of a Public Health Emergency (“the PHE”) issued by the Department of Health and Human Services (“HHS”) on January 31, 2020 officially comes to an end on May 11, 2023. The end of the PHE brings both challenges and opportunities for telehealth and other digital health companies here in the U.S.
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