In the News

Vibhu Yadav, Dushyant Kumar and Nancy Mathewson outlines medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes.

This article by Robert Cumming and Nancy Mathewson discusses the organization and functions of the Medical Device Coordination Group established under the new EU Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation.

Xiaochun Yu and Derek Wood provide a detailed overview of extractables and leachables.

In this article written by Karen Kaucic, Horacio Plotkin and Christopher Komelasky, the authors discuss how rare disease research can be solved with virtual trials and their supporting technologies.

In this two-part series, John Watkins and Clare Ryder highlight the similarities and differences in global submission requirements.

Jai Balkissoon, M.D., and Elizabeth Madichie offer their thoughts one year later on the Cancer Moonshot and combination therapies, two of the key trends PharmaVOICE identified for 2017.

Susan Atkinson comments on risk-based monitoring in this feature in which industry experts identify the trends they think will impact life sciences in the coming year.

In this article written by Katie Matys and Janine McKnight, the authors discuss how the right biomarker can make all the difference in a drug-development program.

In this two-part series, John Watkins and Clare Ryder highlight the similarities and differences in global submission requirements.