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, Lynette A. Zentgraft, Jessica Ringel.

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FDA issues proposed rule amending regulations regarding acceptance of data from clinical studies for medical devices *

USA - March 11 2013
On February 25, 2013, the U.S. Food and Drug Administration (FDA) released a proposed rule entitled Human Subject Protection: Acceptance of Data From…

Co-authors: Elaine Tseng, Laurie A. Clarke, Beverly H. Lorell, MD, Lynette A. Zentgraft, Marian Lee .

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FDA issues final guidance on financial disclosure by clinical investigators *

USA - March 7 2013
On March 1, 2013, the U.S. Food and Drug Administration (FDA or "the Agency") published a final guidance entitled, "Guidance for Clinical…

Co-authors: Elaine Tseng, Laurie A. Clarke, Elizabeth F Gluck , Beverly H. Lorell, MD, Marian Lee .

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FDA issues draft guidance on Medical Device Recalls *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On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical…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, Beverly H. Lorell, MD, Steven Niedelman , Jessica Ringel.

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FDA issues supplemental notice of proposed rulemaking and draft guidance regarding inclusion of pediatric subpopulation information in certain medical device submissions *

USA - February 22 2013
On February 19, 2013, FDA issued a supplemental notice of proposed rulemaking in the Federal Register, re-proposing amendments regarding information…

Co-authors: Elaine Tseng, Laurie A. Clarke, Ami Patel , Lynette A. Zentgraft, Marian Lee .

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