A federal court sentences Kristjan Thorkelson (Manitoba, Canada) and several associated Canadian companies to forfeit $29 million in illegal proceeds ...
FDA Review posts the Federal Register notices for the week ending 7/13/2018.
Federal Register notice: FDA makes available a draft guidance entitled Long Term Follow-Up After Administration of Human Gene Therapy Products.
Federal Register notice: FDA makes available a draft guidance entitled Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication ...
FDA releases a 32-page FDA-483 with 11 observations from an inspection at Hospira Healthcare India.
FDA commissioner Scott Gottlieb says the agency plans to take a broader effort to help the drug industry to convert to more innovative and efficient m...
Three stakeholders raise some concerns about an FDA proposal for an expanded 510(k) pathway.