Richard Starr

Richard Starr

Venable LLP

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FDA Issues a New Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements

As promised last month, we are happy to announce that on April 3, FDA issued the New Dietary Ingredient Notification Master Files for Dietary Supplements draft guidance. In a related constituent update, FDA explained that the...more

4/8/2024  /  Comment Period , Dietary Supplements , Draft Guidance , Food and Drug Administration (FDA)

Medical Device Update: FDA Publishes Three New Guidance Documents for the 510(k) Premarket Notification Program

The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket Notification program for...more

10/9/2023  /  Clinical Evaluations , Comment Period , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , New Guidance , Premarket Approval Applications
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