Paramus, NJ
In response to the many pharmaceutical, biotech, device and diagnostic companies seeking assistance with the new Food and Drug Administration (FDA) laws, the REMS Group LLC today announced its formation.
"We meet with our clients to review their product attributes, design a REMS program that will meet the FDA's high standards, and implement the REMS initiatives," said Nicole Stouffer, president of the REMS Group. "Our continual focus on enterprise and sales rep training and vital communications helps to ensure timely, successful product launches and continued marketing efforts."
During the drug application process, the FDA requires a REMS plan to ensure that the benefits of a drug outweigh the risks of the drug. In addition, the FDA may require the submission of a REMS for an already-approved drug if the FDA becomes aware of new safety information.
The FDA has since required REMS of various drugs in the new drug application process as well as in the post-approval environment. Notably, the FDA recently announced the first class-wide REMS requirements for opioid drugs.
Phase III SELECT-GCA Trial Results Lead to FDA Approval of Rinvoq for Giant Cell Arteritis
April 30th 2025Rinvoq (upadacitinib) becomes the first oral JAK inhibitor approved by the FDA for the treatment of giant cell arteritis in adults, following robust data from the Phase III SELECT-GCA trial demonstrating its efficacy in achieving sustained remission and reducing glucocorticoid exposure.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Landmark Phase III Trial Shows Keytruda Significantly Improves Event-Free Survival in LA-HNSCC
April 28th 2025Interim KEYNOTE-689 trial data show that perioperative Keytruda significantly lowers the risk of disease progression or recurrence in resectable, locally advanced head and neck squamous cell carcinoma, marking the first major clinical advance for this patient population in more than two decades.