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

FDA Law

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. clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

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Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials

FDA Law

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

Clinic 59
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Writing for the Lay Public: Rosanne Leipzig and Louise Aronson

GeriPal

We have two authors, books, op-eds, prolific authors, and today’s podcast is a two-part special. So this week we’re going to be talking about writing for the lay public, and next week we’ll be publishing a podcast on writing for healthcare providers. I give hour long talks on this and do three hour long workshops.

IT 106