ABIM

JUNE 20, 2025

ABIM is pleased to announce openings on the Board of Directors , ABIM Council and several Specialty Boards for initial three-year terms beginning July 1, 2026. ABIM Governance provides a meaningful and rewarding opportunity to join outstanding colleagues in service to the profession and to patients. RN, BSN, PA, NP, Pharm.D.)

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PEMBlog

OCTOBER 31, 2024

Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts. However, for pediatric gastroenteritis, the evidence suggests they do not provide significant benefits. N Engl J Med 2018; 379:2015-2026. N Engl J Med. 2018 Nov 22;379(21):2002-2014.

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FDA Law Blog

NOVEMBER 11, 2024

As dictated by the process provided for in the 2020 CARES Act, FDA announced issuance of the proposed order in a Federal Register notice and published the proposed order itself on FDA’s website. Notably, the proposed order provides that the order, if finalized, will become effective one year after the final rule is published.

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FDA Law Blog

OCTOBER 4, 2023

Note that Astellas withdrew its lawsuit after none of its drugs were selected for price reduction in 2026—potentially because that fact cut against its argument for standing. In any case, no Court can provide relief from economic harm that has already occurred because sovereign immunity bars the court from granting damages.

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FDA Law Blog

SEPTEMBER 16, 2024

Regarding CDER’s ETP, the current ETP guidance document, originally published in 2017, will be updated by the end of 2026, and will include details on communicating the type of products and stages of development for which a requestor can approach the ETP. Implementation of the Advanced Manufacturing Technology Designation Program.

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FDA Law Blog

FEBRUARY 2, 2025

Please note these helpful Nonresident Pharmacy Licensure FAQs California Pharmacists can continue to provide oral therapeutics to patients after a positive Covid-19 diagnosis. California pharmacists are still able to provide the oral therapeutics without requiring you to visit your primary care physician through January 1, 2026.

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FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. Prior to February 2, 2026, FDA also said that it does not intend to enforce complaint requirements under 21 CFR 820.198 for developers that are already in compliance with the complaint requirements under ISO 13485.

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FDA Law Blog

OCTOBER 13, 2024

No rare pediatric disease vouchers could be awarded even to designated applications after September 30, 2026. While the dates have been written in the law, the previous extensions provided a reasonable hope that the program would continue. We heard and felt the anxiety from many of our clients about the uncertainty this caused.

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FDA Law Blog

SEPTEMBER 20, 2021

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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FDA Law Blog

FEBRUARY 11, 2025

However, as we suggested in a recent blog post , the statute did not actually provide any limitations on FDAs authority to grant rare pediatric disease designations , only its authority to grant vouchers.

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FDA Law Blog

APRIL 14, 2022

The draft MDUFA V commitment letter starts with a 70% goal in FY 2023, but if the de novo decision goal is met in FY 2023 and the fee revenue amount provided for FY 2026 and 2027 is adequate to support performance improvements, FDA plans to increase the goal to 80% in FY 2026. We are, certainly, supportive of this effort.

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FDA Law Blog

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.

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FDA Law Blog

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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FDA Law Blog

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance.

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Alabama Academy of Family Physicians

FEBRUARY 19, 2025

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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ABIM

JUNE 4, 2025

Lash, MD, Chief Medical Officer for the Endocrine Society, highlighted the society’s advocacy work, including the “Take Action” page on its website, which provides physicians with the information and tools they need to contact their legislators on specific issues affecting the discipline.

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ABIM

JUNE 24, 2025

Advanced Practice Providers in the Hematology-Oncology Workforce* Guinevere Z. Lillie, MSN, FNP-C, AOCNP , a public member of the Hematology Board and advanced practice provider (APP) at the Inova Schar Cancer Institute, led a discussion about the integration of APPs in hematology and differences among clinical practices.

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ABIM

MAY 30, 2025

The Nephrology Board does not currently have a member who is a private practice general nephrologist and agreed to give special consideration to applicants from non-university, community settings for the next opening that will occur in July 2026. ABIM will begin accepting applications for that opening and others later this year.

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FDA Law Blog

JULY 7, 2024

To be sure, Table 2 provides a handy visual of the categories of LDTs, the timeline for phaseout, and the scope of enforcement discretion for each test category. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements.

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FDA Law Blog

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).

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ABIM

JUNE 11, 2025

Several members of the Infectious Disease Board noted that allowing applicants to select multiple categories and provide written details helps reflect the diversity of practice in the field.

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FDA Law Blog

OCTOBER 20, 2022

FY 2026, device manufacturers should take advantage of reduced fees if they qualify as a small business. In our next blog post, we will provide practical guidance on applying as such through FDA’s Small Business Determination Program.

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FDA Law Blog

NOVEMBER 17, 2022

To implement the Tap Pilot, CDRH plans to build dedicated teams of advisors trained to provide feedback and advice tailored to the specific needs of each developer. Devices in the Safer Technologies Program (STeP) will be included in FY 2026. See Announcement. The TAP Pilot will first focus on CDRH-designated breakthrough devices.

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FDA Law Blog

NOVEMBER 22, 2022

Entities covered under the final rule must maintain and provide to their supply chain partners certain Key Data Elements (KDEs) for Critical Tracking Events (CTEs) throughout the supply chain. FDA will hold a webinar to provide an in-depth overview of the final rule and Q&A on Dec. 7, 2022 at 1 p.m.

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FDA Law Blog

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.

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FDA Law Blog

NOVEMBER 21, 2022

To implement the Tap Pilot, CDRH plans to build dedicated teams of advisors trained to provide feedback and advice tailored to the specific needs of each developer. Devices in the Safer Technologies Program (STeP) will be included in FY 2026. See Announcement. The TAP Pilot will first focus on CDRH-designated breakthrough devices.

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GeriPal

APRIL 3, 2025

I will always, as always, say, you know, you’re welcome to do this in 2026. I honestly thought probably not for 2026 because it’s virtual. Nancy 03:05 And just not to do any sort of spoiler alert here, but 2025 is their last time doing this session at AGS. Of course. We will step aside. Speaker 6 03:29 Andy. Like a song.

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

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FDA Law Blog

AUGUST 3, 2021

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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FDA Law Blog

FEBRUARY 20, 2025

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. This raises the question of whether and to what extent, if the rule moves forward, will FDA provide any tools to help laboratories as they seek to comply with these new requirements.

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FDA Law Blog

SEPTEMBER 14, 2021

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. PART 2: INFLATION REBATES UNDER MEDICARE PARTS B AND D. Subtitle E would go further and prohibit implementation of the rule altogether. * * *.

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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.

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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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