Tag Archives: Food Drug and Cosmetic Act (FDCA)

Recent Traction In FDA’s Development of the 503A and 503B Bulks Lists

Just as the U.S. Food & Drug Administration (“FDA”) promised in its 2019 compounding priorities statement, FDA published a notice and proposed rule in the Federal Register in the past week related to bulk drug substances that can be compounded subject to the conditions of Section 503A and Section 503B of the Federal Food, Drug, … Continue Reading

FDA Announces Public Hearing on Regulation of Cannabis and Cannabis-Derived Products

The Food and Drug Administration (FDA) will hold a public hearing on May 31, 2019, “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.”1 This offers those within the cannabis industry a unique opportunity to speak on their concerns and interests … Continue Reading

Is Your Software a Medical Device? FDA Weighs-in with New Draft Guidances

On December 8, 2017 – nearly a year after President Obama signed into law the 21st Century Cures Act (“Cures Act”) – the Food and Drug Administration (“FDA”) released two new draft guidances that aim to implement section 3060 of the Cures Act, and provide clarity on the Agency’s regulatory approach to software as a … Continue Reading
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