Category Archives: Regulatory

Premier Research’s Chief Medical Officer discusses bridging the regulatory engagement gap from pre-clinical to first patient in at Outsourcing in Clinical Trials New England in Boston. Topics include: – Early regulatory engagement and creating a sound development strategy – Assessment and hiring of key staff members: which positions to fill immediately and which can waitRead more

It isn’t difficult to see how technology has changed our lives for the better over the last century. From self-driving cars to smartphones, numerous innovations have made our lives safer and much more convenient. Of course, one of the most robust categories where the quality of life has improved is medicine thanks to ongoing technologicalRead more

DURHAM, N.C., November 2, 2018 — Premier Research’s Chief Medical Officer will discuss bridging the regulatory engagement gap from pre-clinical to first patient in at Outsourcing in Clinical Trials New England, November 6, in Boston. Dr. Colin Hayward will address strategic and practical considerations for engaging with regulatory bodies on the opening day of the annualRead more

Small and mid-size biopharma companies in the U.S. and Europe are under intense pressure to find more efficient and cost-effective ways to commercialize their products. In an increasingly competitive clinical trial environment, sponsors have begun to shift their focus to the Asia-Pacific (APAC) region for their studies. In fact, the number of clinical trials inRead more

Meet us at PCT Europe 2018! If the United Kingdom’s plan to exit the European Union evokes thoughts of a perilous road of steep grades and switchbacks, you’re pretty well attuned to the politically and commercially fraught process known as Brexit. More than two years after British voters elected to split from the EU, itRead more

If you sell medical devices in Europe and haven’t made plans to comply with the EU’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), it’s time to step things up. The new MDR and IVDR rules adopted a little over a year ago do have generous phase-in periods — three years forRead more

Inadequate funding and burdensome regulatory barriers in the United States are two challenges that must be tackled if clinical researchers are to answer important public health questions about the pros and cons of cannabis and cannabinoid use, one of the world’s leading scientific bodies has concluded. These are among nearly 100 conclusions and recommendations reachedRead more

According to a Council of Foreign Relations report, ensuring a safe and secure healthcare marketplace that can provide innovative therapies is no longer an undertaking for a single nation. The report concludes there is no way a single government regulator, including the gold-standard U.S. Food and Drug Administration (FDA), can support innovation and regulate productsRead more

On June 25, 2018, the U.S. Food and Drug Administration (FDA) approved Epidiolex (cannabidiol, or CBD) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. In addition to ushering in the first-ever approved drug for Dravet syndrome, the greenlighting of Epidiolex marks theRead more

In May 2012, the leaders of 30 medicine regulatory bodies from around the world gathered at the 65th World Health Assembly in Geneva, collectively puzzling over how to improve cooperation among them. Their answer came later that year: form the International Coalition of Medicines Regulatory Authorities (ICMRA), a voluntary group of Heads of Agency (HoA)Read more

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