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On April 24, 2019, the Food and Drug Administration (“FDA”) released a draft guidance, entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7...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.
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.
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.
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.
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On April 27, 2018, the U.S. Food and Drug Administration issued draft guidance on the regulation of devices with multiple functions.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.
