by Maya Caldwell | Aug 2, 2017
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...
by Maya Caldwell | Jul 31, 2017
On Thursday, July 27th the US Food and Drug Administration released details on its plans for regulating digital health technologies. Additionally, FDA shared information about its upcoming pilot program to pre-certify software-based medical devices. In accordance with...
by Maya Caldwell | Jul 27, 2017
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...
by Maya Caldwell | Jul 24, 2017
The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) detailed changes to its process for handling requests for the agency to recognize new voluntary consensus standards for medical devices. CDRH announced the changes last week as...
by Maya Caldwell | Jul 21, 2017
According to Business Insider, “Wall Street is interested in the companies that help drug makers research and develop drugs.”1 Those companies are also known as contract research organizations (CROs) and are becoming increasingly important for the pharmaceutical...