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...
Kunal Sampat, MNA, senior manager for Clinical Trial Programs at Abbott Vascular believes that data should lead the way it comes to site selection. He says, “let data drive your site selection decisions” and “don’t support lousy site seletion.”1 His other tips...
Doctors told T.J. Sharpe that they would be surprised if he was still alive in two years. That conversation occurred five years ago. Clinical trial practitioners helped Sharpe beat the odds. Sharpe says, “You and I can’t cure cancer, but we can help the people who...
Gretchen Bowker, Co-founder and COO of Pearl IRB, will lead a session of the Health-Related Foods Track at this year’s RAPS Convergence in National Harbor, MD. The session, titled “Functional Foods and Dietary Supplements: Manufacturing, Claims, and...
