Tag: Regulatory
ISO 20387:2018: The Key to Quality Biobanking
In the last two decades, clinical research has grown exponentially; therefore, the demand for high-quality biological samples has increased, not to mention the last two years. The most recent pandemic has accelerated the need to optimize and automate processes...
CloudLIMS’ Complimentary Talk on Regulatory Challenges in Biobanking
Wilmington, Delaware – February 8, 2022, CloudLIMS, a leading provider of laboratory informatics, is pleased to announce its talk at the IBS 2022 Virtual Symposium scheduled on February 22, 2022.
Their COO, Shonali Paul, is delivering a talk at the...
Finding The Right Balance – Return of Results to Biobank Participants
In the course of research based on a biobank population occasionally a condition may be revealed in a particular individual, which was not known before the study, and for which the study was not explicitly designed. This is known...
FDA Calls Out Companies Marketing Stem Cell Products Without BLA Approval
The U.S. Food and Drug Administration has warned Genetech,
Inc. of San Diego, California and its president, Edwin N. Pinos for marketing
stem cell products without FDA approval and for significant deviations from
current good tissue practice (CGTP) and current good manufacturing...
Mustang Bio And FDA Complete Pre-IND Meeting For MB-102 (CD123 CAR-T)
Mustang Bio, Inc., a Fortress Biotech Company, headquartered in the greater New York City area, is a clinical‐stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to leverage the patient’s own immune system...
