Drug Development & Delivery – Device Regulations, Early Preparation Will Pay Big Dividends as EU Enacts New EU Device Regulationsby Joanne Emmett, Vice President, Medical Devices
First produced in June 1996, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and reporting trials that involve human subjects. The objective of the standard is to ensure that...
Recent updates to the ICH Good Clinical Practice guidelines call for implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting that are intended to increase clinical trial quality and efficiency while continuing to ensure human subject protection and data integrity. Now, biotech and specialty pharma innovators face even...
Concern over cybersecurity touches our lives in new ways almost daily. Today, there is growing concern over millions of people who use connected medical devices that use off-the-shelf software. Here are six things the FDA’s Center for Devices and Radiological Health wants you to know about the safety of networked medical devices: 1. Hacking of...
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 New direction is contained in two new agency draft guidance documents recently published by the agency.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...
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...
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...
Early oncology trials have changed for the better over the last few years thanks to novel investigational agents, innovations in trial design, and changes to regulatory practices. Among other improvements, these changes have helped to perfect the way study designers plan early phase dosing. Dosing strategies in Phase I trials First-in-human trials When an investigational agent is administered...
Before starting Phase 1 trials, an Investigational New Drug (IND) application must be approved by the FDA. This critical early step in clinical trial development grants an exemption to laws prohibiting the transportation of drugs across state lines prior to market approval. The three major required areas of information in an IND include: Animal pharmacology...
The use of Clinical Endpoint Committees for centralized adjudication of efficacy and/or safety endpoints can help to standardize outcomes and optimize the quality of clinical trial data, driving study success. Some compounds and many devices face the challenge of defining efficacy or safety endpoints so that they are scientifically measurable, objective, and valid. Often, clinical...