Pamela Wible MD

MAY 21, 2025

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. Sponsorships available for medical students and residents. Are you a physician craving purpose, peace, or a path out of burnout? Tax-deductible.

Private Practice 180

Private Practice Consulting Medical Student Engineering 180

FDA Law Blog

SEPTEMBER 20, 2021

STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

ABIM

JUNE 4, 2025

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*. See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.)

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

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.

Manufacturing 64

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. 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.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

FDA Law Blog

FEBRUARY 20, 2025

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. In contrast, AMP and ACLA both asserted that the rule would harm medical care.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102