Articles and Blogs


Homeopathic Products Manufacturers Beware – FDA Steps Up Plans for New Enforcement Regime


Posted on October 25, 2019 in Health Law News

Published by: Hall Render

The centuries-old practice of homeopathic medicine, which has been the subject of much controversy and debate for nearly the entire length of its existence, may finally be going to the mat with the Food & Drug Administration (“FDA”). Amidst growth in the homeopathic products industry and associated concerns with their safety, efficacy and quality,... READ MORE

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FDA Issues New Draft MOU for 503A Compounders Governing Cross-Border Dispensing and Comments Related to CGMP Compliance for Outsourcing Facilities


Posted on November 2, 2018 in Health Law News

Published by: Hall Render

On September 7, 2018, the United States Food and Drug Administration (“FDA”) issued a revised draft Memorandum of Understanding (“MOU”) that would govern interstate dispensing and distribution of “inordinate amounts” of compounded prescription drugs by certain compounding physicians and pharmacies. The concept of this MOU first appeared in the Compliance Policy Guidance issued by... READ MORE

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