The 21st Century Cures Act, signed into law on December 13, 2016, includes several provisions related to regenerative medicine. Regenerative medicine covers a wide range of innovative products including cell therapies, therapeutic tissue engineering products, human...
The US FDA released draft guidance this week on the “problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in drug and biologic clinical trials,” Zachary Brennan of RAPS reports. The FDA...
Two weeks ago, the US Food and Drug Administration (FDA) announced the withdrawal of a proposed rule from 2001. The rule would have required the public disclosure of summaries of safety and effectiveness data from pre-market clinical trials of gene therapies and...
On November 22nd, Pearl Pathways COO, Gretchen Bowker, MS, RAC, FRAPS will lecture on the topic “Drug Development: Goin’ to the FDA” for the Indiana Clinical and Translational Sciences Institute (CTSI) Fall 2016 course – Tools and Techniques in Translational...
Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs draft was released recently by the FDA and the Office for Human Research Protections (OHRP). This new draft guidance includes an IRB Written Procedures Checklist developed with the...
In January of 2016, a Phase I drug trial in France, conducted by the French contract research organization Biotrial, left one volunteer dead and five others hospitalized: four with permanent neurological damage. The drug, named BIA 10-2474, is under development, by...
