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New FDA Draft Guidance on Voluntary Recalls Asks: Are You Prepared?

USA - May 6 2019 On April 24, 2019, the Food and Drug Administration (“FDA”) released a draft guidance, entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7...

Joshua Oyster, Jessica DeLalio.

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, Joshua Oyster, Kathryn C. Thornton.

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, Joshua Oyster.

FDA Clarifies Communication Rules for Medical Product Companies

USA - June 22 2018 On June 12, 2018, the U.S. Food and Drug Administration issued two key documents outlining the agency's current thinking regarding drug and device...

Emerson Siegle, Douglas Hallward-Driemeier, Albert F. Cacozza, Jr, Kellie B. Combs.

Lessons From FDA Draft Guidance On Multifunctional Devices

USA - May 24 2018 On April 27, 2018, the U.S. Food and Drug Administration issued draft guidance on the regulation of devices with multiple functions. The draft...

Abram S. Barth.