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FDA Clarifies Evidence Used to Determine “Intended Use” of Medical Products

USA - October 6 2020 On September 23, 2020, the U.S. Food and Drug Administration (FDA) published a proposed rule amending the agency’s regulations concerning “intended…

Frederick R. Ball

New MAPP Explains Process for Changing Ownership of Generic Drug Applications

USA - September 8 2020 Where a change to a drug application results from a corporate merger or acquisition, the OGD staff will not consider such a change to be a transfer…

Frederick R. Ball, Patrick C. Gallagher, Ph.D.

New Guidance Reveals FDA's Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements

USA - August 27 2020 Under FDA regulations, the “responsible party” or the “submitter” (these are often the same individual or entity) must provide FDA with certain…

Frederick R. Ball, Sandra G. Stoneman

DEA Issues Interim Final Rule Concerning Marijuana and Hemp

USA - August 24 2020 Alerts and Updates The DEA has not issued a warning or otherwise signaled a change in Enforcement Policy by issuing the interim final rule. On August…

Seth A. Goldberg

FDA Clarifies Policy on Scope of Review of Multiple-Function Device Products

USA - August 6 2020 On July 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance containing its current thinking, policies and recommendations relating to…

Frederick R. Ball, Patrick C. Gallagher, Ph.D.