Are disclosure forms important?

Approximately one third of all FDA-approved drugs carry a boxed warning in the manufacturer’s full prescribing information. Clinical trial consent forms document and facilitate the study participant’s consent process. Bhattacharya et al (2015) assessed whether...

21st Century Cares Act gets passed by Congress

The 21st Century Cares Act was passed with an overwhelming majority on July 10th, 2015. This bill would increase the funding for both the NIH and FDA and instate a new framework for evaluating patience’s experience with drugs risks and benefits. Not only will the bill...

FDA: Using EHR-EDC for clinical trials?

The US Food and Drug Administration (FDA) has been looking into ways to test Electric Health Record (EHR)-to-Electric Data Capture (EDC) approach for clinical trials. The administration believes that this could open up new opportunities for clinical trials through...

IMDMC workshop on June 25th. Register now

The Indiana Medical Device Manufacturers Council (IMDMC) is holding an event on the background of FDA regulation for those new to the medical device field. There will be multiple presentations, including one from Pearl Pathways’ Gretchen Bowker COO & RAC on,...

US FDA’s biosimilar guidance has some people concerned

After the recent issuing of three final guidance’s by the US FDA, there have been many speculations. Some supporter favor these final documents, while others fear the documents led to the risk of “taking a copycat product.” There are two main groups that reached out...