We’ve gathered questions from our customers and vendors regarding potential impact of COVID-19 on current and planned studies. Although we may not have answers for every situation, here are some areas that we are keenly focused on to support our sponsors: For more information on Premier’s capabilities, click here.
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As those working in the development of combination products likely know, the Food and Drug Administration (FDA) issued two new draft guidances in December 2019. The guidances – Requesting FDA Feedback on Combination Products and Bridging for Drug-Device and Biologic-Device Combination Products– were published in response to the 21st Century Cures Act and Prescription Drug…
In October 2018, the Food and Drug Administration (FDA) issued Standard Operating Policy and Procedure (SOPP) – SOPP 8214 Version 1.0: INTERACT Meetings with Sponsors for Drugs and Biological Products. This document details recommendations for the Center for Biologics Evaluation and Research (CBER)’s engagement with sponsors (such as industry and investigators) in an early development…
For medical device developers seeking to enter the diverse, complex Asia-Pacific (APAC) market, having a well-planned reimbursement strategy is critical for commercial success. Thoughtful consideration of coverage, coding, and payment should be factored into the product development cycle at its earliest stages, and understanding the reimbursement landscape in all the countries in which you intend…
Oncology & Hematology
Considerations for Operationalizing Pediatric Oncology Studies
Remarkable progress has been made in our understanding of the genomics of pediatric cancers, and these advancements have led to the recognition that products being studied for use in adult cancer indications may have health benefits for pediatric patients. By closing the orphan drug exemption loophole and enabling earlier discussions with the FDA, the Research…
The upcoming compliance deadlines for the European Union Medical Device Regulation (EU MDR) have dominated conversations about the increasingly complex regulatory landscape device manufacturers are facing. But it’s important for device manufacturers to remember that regulations are shifting elsewhere in the world as well, including in the Asia-Pacific (APAC) region. In this post, we explore…
At Premier Research, we attend a lot of events throughout the year – and through these events, we have the opportunity to meet individuals from all sides of the clinical development process. At the recent Global Genes RARE Patient Advocacy Summit, we met countless patients, advocates, and their families, including Kim Tuminello and her daughter…
Oncology & Hematology
Understanding Recent Regulatory Changes for Pediatric Oncology Trials
Of the 1.7 million new cases of cancer in the U.S. in 2018, 10,590 involved children aged 14 or younger.[1] While children typically have a better cure rate for cancer, biopharma companies have traditionally shied away from pediatric oncology trials, resulting in fewer treatment options. However, the regulatory landscape is evolving, and the demand for…
The EU Medical Devices Regulation (MDR) was published on May 5, 2017. The impetus behind these new, more rigorous regulations was in part to reflect the substantial technological and scientific advances made by the medical device sector and in part a response to the need for regulations that would significantly tighten the controls around medical…
Connected medical devices, like all other computer systems, are vulnerable to threats that may lead to compromise of data confidentiality, integrity, and availability. To address these challenges, the Healthcare and Public Health Sector Coordinating Council (HSCC) Joint Cybersecurity Working Group recently issued the Medical Device and Health Information Technology (IT) Joint Security Plan (JSP). [1]…