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(Patient) safety first: take steps now to promote good governance by your board

USA - September 8 2022 Earlier this year, the Delaware Chancery Court approved a breathtaking $237.5 million settlement of derivative claims brought against Boeing’s board…

Blake E. Wilson

Six strategies for clinical trial & marketing application success as FDA requires HCT/P BLAs

USA - August 13 2022 Now that FDA’s grace period for regenerative medicines has ended, many manufacturers of human cell, tissue, or cellular- or tissue-based products…

Robert Church, Mike Druckman

FDA plans to expand remote evaluations, record reviews post-pandemic

USA - August 13 2022 The U.S. Food and Drug Administration (FDA) recently issued draft guidance on how it will continue to conduct remote regulatory assessments (RRAs)…

Jodi Scott, Blake E. Wilson

Demy-Colton panel explains how to future-proof your market access strategy

USA - June 30 2022 Hogan Lovells has teamed up with Demy-Colton to host a special three-part webinar series focused on U.S. market access for life sciences firms…

Alice Valder Curran

Unapproved stem cell therapies remains a top FDA enforcement priority

USA - June 16 2022 Speaking Tuesday at the Food and Drug Law Institute (FDLI) Annual Conference, Mark Raza, FDA Chief Counsel, discussed the investigations priorities…

Akosua Tuffuor