FDA 510(k) rescission authority upheld - U.S. District Court finds for FDA in ReGen litigation *

USA - May 21 2013
The United States District Court for the District of Columbia issued an opinion in Ivy Sports Medicine, Inc. v. Sebelius, a lawsuit filed in May 2011…

Co-authors: Edward M. Basile, Laurie A. Clarke, Pamela F. Forrest, Lynette A. Zentgraft.

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FDA issues draft guidance on Medical Device Recalls *

USA - February 28 2013
On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical…

Co-authors: Elaine Tseng, Laurie A. Clarke, Pamela F. Forrest, Beverly H. Lorell, MD, Steven Niedelman .

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FDA issues final rule regarding CGMPs for Combination Products *

USA - January 31 2013
On Tuesday, January 22, 2013, the United States Food and Drug Administration (FDA or "the Agency") published a final rule regarding Current Good…

Co-authors: Elaine Tseng, Mark S. Brown, Pamela F. Forrest.

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FDA issues proposed unique device identifier rule *

USA - July 30 2012
On July 10, 2012, the Food and Drug Administration (FDA or “the Agency”) published a proposed rule entitled Unique Device Identification System.

Co-authors: Edward M. Basile, Elaine Tseng, Mark S. Brown, Pamela F. Forrest, Beverly H. Lorell, MD.

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FDA issues draft guidance on mobile medical apps *

USA - July 25 2011
On July 19, 2011, the U.S. Food and Drug Administration (FDA or the Agency) released a “Draft Guidance for Industry and Food and Drug Administration Staff” on “Mobile Medical Applications.”

Co-authors: Edward M. Basile, Laurie A. Clarke, Beverly H. Lorell, MD, Marian Lee .

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