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O.K. Corral: FDA sets stage to appeal California Stem Cell Treatment Center decision

USA - January 19 2023 Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a…

Ashley Grey, Meredith Manning

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, Lowell Zeta

California enforcing broad “stewardship program” requirement for pharmaceutical companies

USA - July 28 2022 California’s Pharmaceutical and Sharps Waste Stewardship Act requires pharmaceutical companies doing business in the state to develop and submit a…

Tom Boer, Diana Pfeffer Martin

Biotech Start-Ups: Formation, Funding, and IP Licensing

USA - July 13 2022 Biotech Start-Ups: Formation, Funding, and IP Licensing

Barry Burgdorf, Andrew L. Strong

World Stem Cell Summit panel cautions over stepped up HCT/P enforcement, reimbursement issues

USA - June 30 2022 Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein…

Thomas Beimers, Sally Gu, James Huang, Stuart M. Langbein, Sarah Thompson Schick