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2025 Physician Wellness Retreats | Physician “Burnout” Retreats

Pamela Wible MD

Sponsorships available for medical students and residents. Tax-deductible & includes CME Design Your Coaching Practice Physician Retreat Sept 2–6, 2025 ~ 1:1 personal retreat Curious how to launch a coaching or consulting business as a physician—without an MBA, coaching certification, or a medical license? CME included.

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law

STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. 31, 2022; CDRP start, FY 2023; Public workshop, by July 31, 2025; Strategy document published, by April 30, 2026. Notable Dates and Timelines – New MAPP published, by Dec.

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Endocrinology, Diabetes and Metabolism Board Meeting Summary | Spring 2025

ABIM

See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) They also noted a distinction in telehealth practices between remote consultations in different states and using telehealth to treat patients who live nearby. Community Practice in ABIM Governance* Erica N.

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“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA Law

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. According to Dr. Shuren, the TAP Advisor acts as a consultant, engaging with companies to identify key questions, challenges, and areas requiring strategic problem-solving.

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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law

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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Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Law

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.