February 10, 2023
Navigating the New Frontier of Clinical Trials! Randall Lis shares expert insights on the mandatory CTIS implementation, revolutionizing the EU clinical research landscape. Explore the key trends, benefits, and challenges shaping this transformative journey
January 7, 2023
Cell and gene therapies for treating multiple myeloma, such as CAR-T, have resulted in breakthrough health outcomes for patients. In the last decade, approval of cell and gene therapy (CGT) products has increased significantly. Multiple other products are in clinical development for solid tumors, genetic deficiencies, and infections that promise more effective […]
January 6, 2023
Product development is mainly a sequence of activities. Moving forward to the next step depends upon the result of the previous step. A regulatory deficiency in an early stage will therefore carry forward into all later stages. Fundamental CMC deficiencies at an early stage may require complete subsequent product redevelopment.
October 14, 2022
An Investigational Device Exemption (IDE) is an application submitted to obtain the FDA's approval for use of a novel medical device in a clinical study. This allows for the collection of safety and effectiveness data in order to support full market approval. IDE applications support several types of studies: to […]
August 30, 2022
The pharmaceutical supply chain is a complex network of processes that must work together to ensure patients receive vital medicines promptly and safely. Supply chains can be challenging, but managing them well is the key to successful pharmaceutical business.
August 8, 2022
You've likely heard the phrase “time is money.” No other statement could be more accurate for the medical device industry. Each day your company is not approved to market your device is not only a day of lost revenue, but a day patients don’t get to benefit from the value […]
