Newsletter - September 5, 2019
Drugs Approvals by FDA do not Require Diversity in Clinical Trials
Over the last 10 years, most clinical trials used to support approval of anti-cancer drugs lacked diversity in the trial population with only about 10% including reasonable participation by the four major races – whites, blacks, Hispanics, and Asians – and only about 25% conducting race subgroup analysis to... Read More
FDA Presents a Glimpse of Upcoming Stem Cell Regulation with a New WL
Over the weekend, FDA issued a Warning Letter to Stemell, Inc., a manufacturer of umbilical cord blood stem cells for allogeneic use. The letter contains an element not seen in previous warning letters to stem cell companies that point towards FDA’s strategy for the upcoming enforcement actions on these companies. Read More
Drugs Approvals by FDA do not Require Diversity in Clinical Trials
Over the last 10 years, most clinical trials used to support approval of anti-cancer drugs lacked diversity in the trial population with only about 10% including reasonable participation by the four major races – whites, blacks, Hispanics, and Asians – and only about 25% conducting race subgroup analysis to... Read More
FDA Presents a Glimpse of Upcoming Stem Cell Regulation with a New WL
Over the weekend, FDA issued a Warning Letter to Stemell, Inc., a manufacturer of umbilical cord blood stem cells for allogeneic use. The letter contains an element not seen in previous warning letters to stem cell companies that point towards FDA’s strategy for the upcoming enforcement actions on these companies. Read More
