According to a recent article on the Washington Post, more than 60% of cancer patients are older adults and that number could increase to 70% by 2040. However, seniors are rarely involved with clinical trials, leading to uncertainty with how treatments will affect...
The European Medicine Agency’s new guideline focuses on a sponsor’s responsibility to define the uncertainty associated with the medicines tested in clinical trials. The announcement occurred last week and the EMA guideline will go into effect on January 2nd of 2018....
On August 15th, join our partner Brandwood Biomedical to learn about the Japanese regulatory process. Prior to the internationally harmonized Japanese Pharmaceutical and Medical Devices Law, the process may have seemed obscure but things aren’t as complex as you may...
The Food and Drug Administration (FDA) vows to never forget that their efforts to evaluate and approve new medical products is done to benefit patients. Because of this they are constantly looking to find new ways to incorporate the views and expertise of patients and...
The US Food and Drug Administration (FDA) on Monday, July 24 issued guidance detailing the circumstances to which the agency will not object to waiving or altering informed consent requirements for clinical studies that pose a minimal risk to participants, according...
