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New FDA Draft Guidance on Voluntary Recalls Asks: Are You Prepared?

USA - May 6 2019 On April 24, 2019, the Food and Drug Administration (“FDA”) released a draft guidance, entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7...

Jessica DeLalio, Gregory H. Levine.

Federal Circuit Affirms ITC’s Non-Institution Decision, Offering Guidance for Future FDCA-Related Section 337 Claims

USA - May 2 2019 In its long-awaited decision in Amarin Pharma. V. ITC, the Federal Circuit provided guidance on the U.S. International Trade Commission’s discretion...

Matthew J. Rizzolo, Kathryn C. Thornton, Gregory H. Levine.

FDA’s Draft Guidances on Medical Device Inspection Transparency: Anything New Here?

USA - April 30 2019 Two recent FDA draft guidances respond to directives from Congress to improve transparency with medical device firms regarding inspections, including...

Beth P. Weinman, Gregory H. Levine.