Category Archives: Regulatory

DURHAM, N.C., JULY 30, 2018 — Premier Research, a global provider of clinical development services to biopharmaceutical product innovators, has acquired Regulatory Professionals, Inc. (RPI), a California-based company that provides regulatory expertise and solutions to biotechnology, pharmaceutical, and medical device companies. This partnership will form a new Regulatory Services Division of Premier Research, and DonnaRead more

In a clinical trial landscape where global, multi-center studies have become increasingly common, trial monitoring has become more complex. Regulations require that sponsors of medical device studies perform site monitoring to ensure that investigators are compliant with federal regulations, sponsor agreements, the investigational plan and the requirements set forth in the Investigational Review Board (IRB)Read more

Medical devices are ubiquitous — from thermometers, bandages, and dental floss to blood glucose meters, hearing aids, and complex implantables such as pacemakers. The latest cutting-edge examples even extend to apps on tablets and PCs that physicians use to help monitor and treat patients. To ensure the safety and efficacy of these devices, regulators expectRead more

Like any new medical product, gene therapies must undergo rigorous approval processes. However, there are a number of additional regulations for gene therapies that don’t apply to conventional pharmaceuticals. This is especially true within the European Union. (It’s important to note that while most gene therapy studies are based in the U.S. and Europe — whichRead more

It’s already been three years since the FDA issued its “Guidance on Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” This guidance established a mandatory requirement for electronic submission of certain applications, amendments, supplements, and reports to the FDA’s Center for Biologics Evaluation and Research (CBER)Read more

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. FoodRead more

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: TrendRead more

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, DecemberRead more

The Path to Medical Device Trial Success: Attend Our February 14 Webinar DURHAM, N.C., FEBRUARY 10, 2017 — The medical device regulatory environment is changing as regulators, physicians, health systems, and even patients seek more assurance that products are effective and safe. Premier Research will examine this evolution, and its implications for device makers, atRead more

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