Monthly Archives: May 2019

In recent years, immunotherapy has led to substantial advances in cancer therapy. In particular, the immune checkpoint inhibitors — PD-1/PD-L1 and CTLA-4 inhibitors — have revolutionized treatment for certain hematologic malignancies and solid tumors. To date, the U.S. Food and Drug Administration (FDA) has approved immunotherapies for more than 15 cancer indications. However, widespread useRead more

With the looming deadline for compliance with the EU Medical Devices Regulation (MDR), device manufacturers face a host of questions about how to prepare their existing products for compliance. In this post, we provide answers to top questions about EU MDR compliance. Is it possible to avoid compliance with the EU MDR? The short answerRead more

DURHAM, N.C., May 3, 2019 — Two of our top experts, Joanne Emmett, Vice President of Clinical Development Services for Medical Device and Diagnostics, and Jasmina Jankicevic, MD, MSc, CCRP, Dermatologist, Executive Director, Medical Affairs, will participate in three sessions at the MAGI 2019 East Clinical Research Conference in Boston. Emmett, head of medical devices,Read more

In March 2019, the FDA released draft guidance on the design and implementation of natural history studies to support the development of safe and effective treatments for rare diseases. The document, Rare Diseases: Natural History Studies for Drug Development,[1] addresses one of the major challenges sponsors encounter when developing therapies for rare disease: the lackRead more

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