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Legislators Urge FDA to Act on Hemp-Derived CBD

USA - October 1 2019 Since the enactment of the 2018 Farm Bill, consumer demand has increased dramatically for hemp-derived cannabidiol (CBD) products. In fact, there are…

DEA Announcement on Improving Access to Marijuana Research

USA - September 3 2019 While demand for marijuana for research purposes has increased sharply, the number of suppliers has remained stagnant…

Frederick R. Ball, Seth A. Goldberg, Joseph J. Pangaro

OTC Personal Products Manufacturer Cited by FDA for Various Regulatory Violations

USA - August 27 2019 Until each of the violations are corrected and FDA has confirmed such corrections, FDA may withhold approval of new applications or supplements…

Frederick R. Ball, Justin M. L. Stern

BYOD and eCOA: A Match Made in Heaven?

USA - August 16 2019 Patient-focused drug development and the selection and development of Clinical Outcome Assessments (COA) continue to be a focus for the U.S. Food and…

Frederick R. Ball, Sandra G. Stoneman

FDA Releases Guidance on REMS Modifications and Revisions

USA - August 9 2019 In all cases, the FDA recommends that submissions include a REMS history that outlines all changes made to the REMS since its original approval…

Frederick R. Ball, Evan J. Muller