PEMBlog

OCTOBER 31, 2024

Why is this important for patients and caregivers ? However, this large study shows that probiotics do not significantly shorten illness duration, improve symptoms, or reduce the need for additional medical visits. We found that probiotics did not improve patient outcomes when compared to placebo. N Engl J Med. Freedman et al.

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Hospital Illness Patients Provider 105

ABIM

JUNE 12, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. The ABIM Council approved the pilot earlier this year and submitted it to the American Board of Medical Specialties, the final approval stage before implementation.

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Board-Certified Internal Medicine Government Community 52

FDA Law Blog

FEBRUARY 2, 2025

The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues. The most common drug Californians may be looking for this winter is Paxlovid.

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Primary Care Physician Primary Care Diagnosis Provider 59

FDA Law Blog

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. is it the lab itself, the healthcare provider, or the patient?).

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Manufacturing Electronics Provider Management 64

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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Provider Clinic Medical IT 40

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

ABIM

JUNE 4, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) Community Practice in ABIM Governance* Erica N.

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Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 11, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM. Community Practice in ABIM Governance* Erica N.

Board-Certified 52

Board-Certified Government Community Education 52

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. Senate SB 43 – Patient Price Transparency Bill What’s in the Bill: Sponsored by Sen.

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Insurance Management Hospital Vaccination 130

ABIM

JUNE 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. The group discussed policy shifts and potential implications for graduate medical education and health equity. Above all, ABIM remains focused on its mission.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

ABIM

MAY 30, 2025

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

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

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. Devices in the Safer Technologies Program (STeP) will be included in FY 2026. By Adrienne R. here ), Federal Register notice ( here ) and the Program Website ( here )).

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Medical Patient-Centered Provider IT 59

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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Manufacturing Provider Physicals Electronics 64

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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Manufacturing Medical Patient-Centered Appointment 45

GeriPal

APRIL 3, 2025

I will always, as always, say, you know, you’re welcome to do this in 2026. That was actually Ken, you remember that article, Nancy Schoenberg’s article on screening and what to say and what not to say to patients on how to talk. How to talk to patients about screening colonoscopies. Of course. We will step aside.

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IT Hospital Screening Patients 64

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. Devices in the Safer Technologies Program (STeP) will be included in FY 2026. here ), Federal Register notice ( here ) and the Program Website ( here )).

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Patient-Centered Provider Medical IT 69

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.

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Manufacturing Government Vaccination Utilities 98

Physician's Weekly

JUNE 26, 2025

In the medical odyssey that followed, she suffered double vision, chronic nausea, brain fog, and profound weakness. He directed the patients to seek local help. The HHS budget proposal for fiscal year 2026 makes no mention of vaccine safety programs. Once a rock climber, she became a couch potato. His clinical study was ending.

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Vaccination Patient-Centered Government IT 52

FDA Law Blog

FEBRUARY 20, 2025

Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients. In contrast, AMP and ACLA both asserted that the rule would harm medical care. The materials from this webinar are still available on FDAs website ( here ).

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Patient-Centered Consulting Government Clinic 102