Tag: regulatory

Medical and Regulatory Affairs

Learning to Listen: Voice of the Patient Grows Louder in Product Development

Days before Christmas 2017, a nationwide call went out requesting nominations of patients and caregivers to join a new public/private-sponsored Patient Engagement Collaborative. Among the promised duties for this yet-to-be-filled body of 16 patient community representatives: Propose new collaboration models in which patients and patient advocates are partners in healthcare product development and U.S. Food...

Consulting

7 Questions About Clinical Evaluations for MDR

After years in development, the final version of the Medical Device/In Vitro Diagnostic Medical Device Regulations was published in the Official Journal of the European Union on May 5, 2017. These regulations superseded the previous Directives for the European market and will be implemented over the next few years. In our last post, we went over...

Clinical Research: Phase 1 - Phase 4

Are We Trading Speed for Innovation in Approving New Drugs?

DURHAM, N.C., February 16, 2018 — Are expedited approvals of new drugs occurring at the expense of innovation? Nach Davé, Vice President of Global Regulatory Affairs at Premier Research, will explore the subject at Outsourcing in Clinical Trials West Coast 2018, February 21 in Burlingame, California. In his presentation, Faster Approvals but Less Innovation: Trend...

Medical and Regulatory Affairs

Experts to Discuss EU Regulations at OCT Medical Devices Europe

DURHAM, N.C., February 6, 2018 — Two Premier Research medical device experts will examine the impact of upcoming changes to European medical device regulations at Outsourcing in Clinical Trials Medical Devices Europe 2018. Joanne Emmett, Vice President for Medical Device and Diagnostics, and Janet Kube, Director, Project Management, will discuss the new EU Medical Device...

Consulting

Sponsors and CROs get More Clarity on Precision, Targeted Therapy Trials

Clinical trial sponsors and the clinical research organizations (CROs) supporting them have more clarity from the U.S. Federal Food & Drug Administration (FDA) on how to better select trial participants and design precision-based clinical trials for targeted therapies. New direction is contained in two new agency draft guidance documents recently published by the agency. They...

Consulting

Optimizing Regulatory Considerations for Orphan-Drug Development on a Global Scale

Rare disease and orphan drug research has a long history of serious challenges, thanks to both intrinsic factors—fewer patients means less available data; less available data means a less complete picture—and market forces—it’s more difficult to find investors when a smaller pool of patients may mean a more uncertain potential return on investment. Luckily, recent changes...

Medical and Regulatory Affairs

Stronger Post-Market Studies Needed if FDA Speeds New Medical Device Approval

Big changes are planned in 2018 and beyond for how new medical devices are reviewed and approved by the U.S. Food and Drug Administration (FDA) if a proposal put forth moves forward. In a blogpost this week, FDA Commissioner Scott Gottlieb, M.D. announced the FDA’s Center for Devices and Radiological Health (CDRH) will publish a series...

The Outlook for Orphan Drug Research: A Live Webinar

DURHAM, N.C., DECEMBER 5, 2017 — The outlook for orphan drug research is more promising than ever, with regulators providing a progressive development platform and government reforms putting new emphasis on the need to treat rare diseases. Premier Research will examine the outlook for biotech and pharma companies at a live webinar on Tuesday, December...

Medical and Regulatory Affairs

Premier Research Names Nach Davé VP of Global Regulatory Affairs

DURHAM, N.C., August 7, 2017 — Premier Research announces the appointment of Nach Davé, RPh, MS, as Vice President of Global Regulatory Affairs. He oversees the company’s regulatory affairs service offerings in rare diseases and across its broad range of therapeutic focus areas, bringing to the position more than 20 years of experience in the...

Consulting

21st Century Cures Act: Changes to Medical Device Regulation in the U.S.

In December 2016, the United States passed an important piece of regulatory legislation called the 21st Century Cures Act. These FDA regulations cover multiple types of clinical research but include some specific provisions for medical device development. In contrast to the regulatory reform seen in the EU — which includes a much-needed increased emphasis on...