PEMBlog

OCTOBER 31, 2024

However, this large study shows that probiotics do not significantly shorten illness duration, improve symptoms, or reduce the need for additional medical visits. Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts. N Engl J Med 2018; 379:2015-2026.

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FDA Law Blog

FEBRUARY 2, 2025

The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues. Please note these helpful Nonresident Pharmacy Licensure FAQs California Pharmacists can continue to provide oral therapeutics to patients after a positive Covid-19 diagnosis.

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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

APRIL 14, 2022

Cato — On March 22, FDA announced that it reached agreement with representatives from the medical device industry on proposed recommendations to Congress for the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA V). During the pilot, over 85 testing laboratories have become ASCA accredited (see list here ).

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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. STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs.

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FDA Law Blog

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). FDA provides definitions for the three datasets. Update practices and training of end users also need to be addressed.

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ABIM

JUNE 4, 2025

See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) Dr. Johnson updated the Specialty Board on the pilot proposal, which is currently under review by the American Board of Medical Specialties. Community Practice in ABIM Governance* Erica N. Endocrine Society Robert W.

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Alabama Academy of Family Physicians

FEBRUARY 19, 2025

Running from February 4 to May 15, this session promises to bring substantial changes to medical consent laws, Medicaid coverage, rural hospital funding, taxation on essential goods, and the transparency of healthcare costs. Any contractual clause that limits or penalizes providers for sharing this information would be unenforceable.

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ABIM

JUNE 24, 2025

The group discussed policy shifts and potential implications for graduate medical education and health equity. Dr. McDonald acknowledged that recent executive orders have emphasized more competition in medical and legal education accreditation, but reaffirmed ABIM’s commitment to evidence-based practice and health equity.

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FDA Law Blog

OCTOBER 20, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — you have purchased anything in recent months or kept up with economic reports, you are familiar with the unwelcome observation: “Prices have gone up!” That could not be more true than in the area of medical device user fees. Medical Device User Fees.

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ABIM

JUNE 11, 2025

This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM. Johnson, MD, FACP, FIDSA , Senior Vice President for Academic and Medical Affairs, led a discussion with the Infectious Disease Board on community practice in the specialty to create a more inclusive understanding of its role and scope.

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ABIM

MAY 30, 2025

Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. One notable trend was a higher representation of international medical graduates and osteopathic physicians in the specialty. Rodriguez, MD , Chair of the Nephrology Board, and John C.

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FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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FDA Law Blog

NOVEMBER 21, 2022

The TAP Pilot is intended to “de-risk the medical device valley of death,” the metaphorical place where innovative technologies die while trying to reach the market. 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.

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FDA Law Blog

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027). up to 125 total products enrolled through FY 2025).

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FDA Law Blog

NOVEMBER 17, 2022

The TAP Pilot is intended to “de-risk the medical device valley of death,” the metaphorical place where innovative technologies die while trying to reach the market. 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.

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GeriPal

APRIL 3, 2025

I will always, as always, say, you know, you’re welcome to do this in 2026. So I went to medical school in Chicago and I got engaged in Chicago, and that night we went to a blues club with my sister and my husband, which was really fun. I honestly thought probably not for 2026 because it’s virtual. Of course.

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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

FEBRUARY 20, 2025

In contrast, AMP and ACLA both asserted that the rule would harm medical care. The first phase of the rule, which takes effect in less than three months, requires laboratories to have certain policies and procedures in place to begin handling complaints, reporting Medical Device Reports, and reporting corrections/removals.

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Physician's Weekly

JUNE 26, 2025

In the medical odyssey that followed, she suffered double vision, chronic nausea, brain fog, and profound weakness. The HHS budget proposal for fiscal year 2026 makes no mention of vaccine safety programs. People with covid vaccine injuries, however, are stuck in a kind of limbo, often without clear medical options.

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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. One such group is Sturdevant’s. Trust the Process’?

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