FDA Law Blog
SEPTEMBER 16, 2024
FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. This would include continuous manufacturing, distributed manufacturing, modern aseptic manufacturing equipment and novel analytical methods.
FDA Law Blog
SEPTEMBER 20, 2021
Notable Dates and Timelines – Program opens, beginning of FY 2023; Expediting reviews fully implemented, by FY 2024; Webpage with detailed criteria for acceptance and participation, October 1, 2022; Interim assessment, end of FY 2025; Public workshop, end of Q2 FY 2026. Notable Dates and Timelines – New MAPP published, by Dec.
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Alabama Academy of Family Physicians
FEBRUARY 19, 2025
It then establishes a new Rural Physician Income Tax Credit program, effective January 1, 2026, that provides a $10,000 annual tax credit to qualifying rural physicians for up to four tax years. These funds could be utilized for various purposes, including direct care, operational expenses, and facility maintenance or upgrades.
FDA Law Blog
NOVEMBER 16, 2021
The Act now extends that delay until January 1, 2026. In addition, section 90004 of the Act requires manufactures of drugs sold in single-dose containers to pay refunds to Medicare for discarded Part B drugs. The new refund requirement applies to drugs that are (1) separately paid under Medicare Part B; (2) single source drugs (i.e.,
FDA Law Blog
AUGUST 14, 2022
The number will begin in 2026 with 10 drug covered under Medicare Part D and will increase annually to 20 Part B and 20 Part D drugs by 2029 and thereafter, with the selected drugs accumulating from year to year. that price controls distort markets and reduce competition.
FDA Law Blog
SEPTEMBER 14, 2021
The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.
FDA Law Blog
SEPTEMBER 13, 2021
A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.
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