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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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

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 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

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

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. The program, however, has always had a scheduled sunset date.

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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. While this press release did not specify the date that it was granted, it noted that it closely follow[ed] FDAs clearance of its IND.

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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. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners).

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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. By McKenzie E.

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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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ABIM

JUNE 4, 2025

Christine Twining, MD, Chair, ABIM Endocrinology, Diabetes and Metabolism Board The Endocrinology, Diabetes and Metabolism Board , which meets twice a year and is responsible for oversight of policy and assessment in the specialty, held its spring meeting on April 1, 2025.

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ABIM

JUNE 24, 2025

Gertz, MD, MACP, Chair, ABIM Hematology Board The Hematology Board , which meets twice a year and is responsible for oversight of ABIM policy and assessment in the specialty, held its spring meeting on May 2, 2025. A representative from the American Society of Hematology (ASH) joined for a portion of the meeting*.

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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 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. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations.

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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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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. Rodriguez, MD , Chair of the Nephrology Board, and John C.

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GeriPal

APRIL 3, 2025

I will always, as always, say, you know, you’re welcome to do this in 2026. Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. So this is something. This is the plenary to attend. It is a sold out crowd. Of course. We will step aside. Go Cubs, go.

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FDA Law Blog

JUNE 14, 2023

In the ever-changing landscape of medical device development, FDA is touting steps it is taking that it says will enhance efficiency, foster innovation, and address key challenges faced by developers. Given Dr. Shuren’s propensity to use the phrase, we have yet to see it formally defined by CDRH.

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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. See Announcement. See Program Website.

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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 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. See Announcement. See Program Website.

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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. By Faraz Siddiqui — On Monday August 2, 2021, the Senate took up for review H.R. 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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Physician's Weekly

JUNE 26, 2025

The HHS budget proposal for fiscal year 2026 makes no mention of vaccine safety programs. Kennedy Jr. forced him out in May. While it’s possible that Nath’s patients suffered covid vaccine injuries, Marks said, their symptoms were so varied it was hard to characterize a possible syndrome. The current U.S.

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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. Yesterday our post focused on the Administration’s priorities and initiatives, as described in HHS’s recent Comprehensive Plan for Addressing High Drug Prices.

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Physician's Weekly

JUNE 26, 2025

Gavin Newsom has asked lawmakers to push the implementation date to January 2026, leaving patients, insurers, and employers in limbo. Newsom spokesperson Elana Ross said the state needs more time to provide guidance to insurers on specific services not addressed in the law to ensure adequate and uniform coverage.

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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. In a few days, he would drive from Mississippi to Washington, D.C.,

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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. Last Thursday, the U.S.

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