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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog

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.

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

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Key Bills in the 2025 Legislative Session AAFP is Watching Closely

Alabama Academy of Family Physicians

What Happened: Passed out of the House of Representatives HB 46 – Rural Physicians Tax Credit What’s in the Bill: HB 46 terminates the existing Rural Physician Tax Credit program in Alabama, which provided tax credits to physicians practicing in rural areas, effective December 31, 2025.

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Two Drug-Related Provisions Enacted in Infrastructure Law

FDA Law Blog

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.,

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Landmark Drug Pricing Bill Set to Become Law; HP&M Releases Summary Slide Deck

FDA Law Blog

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.

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Drug Pricing Reform Gathers Steam (Part 2)

FDA Law Blog

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.

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Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law Blog

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.