On March 13 the FDA officially issued a Federal Register notice to explain how the end of the COVID-19 PHE declaration will impact the Agency’s 72 COVID-related guidance documents currently in effect. The notice comes as the Biden administration plans to end the PHE phase of the pandemic response on May 11.
Of the 72
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Stark and AKS Rules Cross the Finish Line of HHS Regulatory Sprint
With a bold finish, the Department of Health and Human Services (HHS) crossed the finish line of its race to modernize and clarify the regulations interpreting the federal physician self-referral law (Stark) and anti-kickback statute (AKS) through final rules released Nov. 20, 2020. With one exception, the Stark and AKS rules, based on October 2019
Capitol Hill Healthcare Update
CORONAVIRUS WORRIES CONTINUE AFTER EMERGENCY FUNDING BILL
Congressional approval last week of emergency spending to address the coronavirus hasn’t allayed Capitol Hill’s concerns about preparedness and response as the impact of the virus in the United States rapidly escalates.
Two lawmakers – Sen. Ted Cruz, R-Texas, and Rep. Paul Gosar, R-Ariz. –
Capitol Hill Healthcare Update
AZAR TO TESTIFY THIS WEEK BEFORE HOUSE, SENATE COMMITTEES
Health and Human Services Secretary Alex Azar faces a marathon week of testimony, appearing before four congressional committees to discuss his department’s fiscal 2021 budget.
In addition to funding issues, Azar is likely to face questions on the federal government’s response to the coronavirus outbreak. Last
Capitol Hill Healthcare Update
CONCERNS ABOUT CORONAVIRUS GROW ON CAPITOL HILL
As coronavirus cases continue to emerge in the United States and worldwide, lawmakers are seeking briefings from federal health officials about the outbreak that originated in China and what steps U.S. health agencies are taking to protect Americans.
Five cases were confirmed in the United States, but there