FDA Law

NOVEMBER 16, 2021

5376 that has garnered the greatest amount of attention (at least in the food and drug law world) is TITLE XIII, Subtitle J (Drug Pricing), Part 1 (Lowering Prices Through Fair Drug Price Negotiation), Section 139001 (Providing for Lower Prices for Certain High-Priced Single Source Drugs). One of the new programs included in the H.R.

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Manufacturing Government IT Complication 52

FDA Law

FEBRUARY 13, 2025

FDA provides definitions for the three datasets. The update procedures should include plans for required labeling changes and training provided to end users. Post-market surveillance plans and procedures (PMS) are a requirement under ISO 13485 which will be adopted into FDAs Quality Management System Regulation in 2026.

Manufacturing 71

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ABIM

JUNE 4, 2025

Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

Diabetes 52

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ABIM

JUNE 24, 2025

Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles. Advanced Practice Providers in the Hematology-Oncology Workforce* Guinevere Z.

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ABIM

JUNE 11, 2025

Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

MAY 30, 2025

Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. Community Practice in ABIM Governance* Erica N. Visit ABIM’s Openings page for the latest governance openings. Rodriguez, MD , Chair of the Nephrology Board, and John C. Siddharta G.

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Board-Certified Government Internal Medicine Private Practice 40

FDA Law

NOVEMBER 16, 2021

The Act now extends that delay until January 1, 2026. Medicare Part B reimburses providers for quantities of drugs packaged in single-use containers that are left over after administration and discarded.

Manufacturing 40

Manufacturing Utilities Management Provider 40

FDA Law

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. Manufacturers receive no benefits in exchange for the inflation rebates.

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FDA Law

AUGUST 3, 2021

The rule was estimated to cost the federal government around $196 billion over ten years. Section 90006 of the proposed infrastructure bill would further delay implementation of the rebate rule until January 1, 2026, providing the government with an estimated savings of $49 billion. See bipartisan bill summary at 5.

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Manufacturing Transportation Government Management 52

FDA Law

FEBRUARY 20, 2025

Given the numerous changes in policy by the Trump administration, there had been much speculation that the government would now take a different position on this Biden-era rule. FDA had been scheduled to hold a webinar on the Stage 2 (May 2026) requirements related to the investigational device requirements for LDTs later this month.

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Physician's Weekly

JUNE 26, 2025

The HHS budget proposal for fiscal year 2026 makes no mention of vaccine safety programs. But the network has published nothing on covid vaccines, nor are any trials related to the issue listed on government websites. As of June 5, a patient group she leads had provided $1.2 ” Asked for details, Hilliard did not respond.

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FDA Law

SEPTEMBER 14, 2021

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged. Subtitle E is a slightly modified version of H.R.

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Manufacturing Insurance Government Patients 52

Physician's Weekly

JUNE 25, 2025

Dangerous changes loomed: To compensate for tax cuts for the wealthy, Trump’s “big, beautiful” bill and budget proposal for fiscal year 2026 threaten to curtail Medicaid, which provides health coverage for people with low incomes and disabilities. He has taken on the role of dad or uncle to many.

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Government Community Family Families 52

FDA Law

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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Manufacturing Supply Chain Patient-Centered Utilities 98