There’s a lot of talk and confusion of the issues involved in the role of compounding pharmacies for topical ocular medications (eyedrops). Please see this interview in EyeWorld in which I am interviewed about regulatory issues. I address the special role which compounding pharmacies have played in the therapeutic process as physicians tailor therapies to individual patients. At the same time, I discuss the issues in the use of compounding pharmacies for larger populations crossing state lines.
I’m pleased to be part of NDA Partners Quantitative Drug Development Strategies Practice – providing drug development guidance to Sponsors.
Together with other senior industry and regulatory consultants, we will be providing expertise in quantitative clinical pharmacology, the application of Bayesian approaches in biostatistics and clinical trial design, and clinical trial modeling and simulation. NDA Partners will support the design and execution of clinical trials that can accelerate development programs and that produce high-quality regulatory packages containing the data needed to secure regulatory approval without delays.
FDA continues to be open during government shut-down, due in part to user fees paid for by industry
The U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 46 new medical entities in 2017. This was a record high for the last ten years. PharmaLogic supported at least two of them, one of them considered to be a first in class.
Dr. Novack gave a presentation at the Second Annual Myopia Society of Japan on 24 November 2017. This was a joint symposium between the Myopia Society Japan and Eye & Contact Lens. The topic was “Controlling Myopia Progression: Where Do We Stand Today?”. In the concluding presentation of the event, Dr. Novack spoke about what it would in time and risk to develop a novel pharmacological treatment to prevent the development of myopia in children. A photo is provided. Dr. Novack is in the center of the back row. Also shown are Penny Asbell MD (Icahn School of Medicine) and Kazuo Tsubota, M.D. (Keio University).