article thumbnail

2025 Physician Wellness Retreats | Physician “Burnout” Retreats

Pamela Wible MD

Whether you’re launching your dream clinic, writing your first book, or exploring shamanic healing or magic mushrooms, these retreats are handcrafted to help you heal, grow, and thrive. 2026 Physician Vision Quest Retreat Dec 3–7, 2025 ~ 1:1 or small group retreat Craving clarity before the new year? Tax-deductible.

article thumbnail

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

FDA Law Blog

The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries. based upon the anticipated clinical benefit of earlier patient access to the product.”. Notable Dates and Timelines – Applications open, Q4 of FY 2023.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Endocrinology, Diabetes and Metabolism Board Meeting Summary | Spring 2025

ABIM

Representatives from the American Association of Clinical Endocrinology (AACE), the Association of Program Directors in Endocrinology, Diabetes and Metabolism (APDEM) and the Endocrine Society joined for a portion of the meeting*.

article thumbnail

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

FDA Law Blog

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. 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).

article thumbnail

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

FDA Law Blog

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R. 820.198). .

article thumbnail

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

FDA Law Blog

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. ACLA, of course, confirmed that was true.

article thumbnail

California’s Much-Touted IVF Law May Be Delayed Until 2026, Leaving Many in the Lurch

Physician's Weekly

Gavin Newsom has asked lawmakers to push the implementation date to January 2026, leaving patients, insurers, and employers in limbo. Amy Donovan, a lawyer at insurance brokerage and consulting firm Keenan & Associates, said the firm has fielded many questions from employers about the possibility of delay.