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At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub

FDA Law Blog

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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News & Notes: Spring 2025

ABIM

Specialties are each on their own review cycle, and several—including Advanced Heart Failure and Transplant Cardiology, Critical Care Medicine, Gastroenterology, Medical Oncology and Transplant Hepatology—are currently under review. Physician feedback is vital to the review process.

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PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information

FDA Law Blog

A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission. eSTAR Templates As we have previously explained in our blog post here , eSTAR is an interactive PDF form designed to assist users in creating “complete” submissions.

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Endocrinology, Diabetes and Metabolism Board Meeting Summary | Spring 2025

ABIM

Christine Twining, MD, Chair, ABIM Endocrinology, Diabetes and Metabolism Board The Endocrinology, Diabetes and Metabolism Board , which meets twice a year and is responsible for oversight of policy and assessment in the specialty, held its spring meeting on April 1, 2025. Visit the ABIM Blog for reports of prior meetings.

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Infectious Disease Board Meeting Summary | Spring 2025

ABIM

Visit the ABIM Blog for reports of prior meetings. This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM. ABIM’s website features expansive sections on research related to assessment and clinical outcomes. The following is a summary of the spring meeting.

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What is primary care? Part 2

Noreta Family Medicine

Part 2 Here are some frequently asked questions I get as a Primary Care Provider. During our post-medical school residency years, we are trained by many different types of doctors including pediatricians, OB/GYNs, surgeons, psychiatrists, neurologists, ENTs and more. Other family doctors only see patients in their clinics.