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).
RxSight, gained US FDA approved for a new type of Intraocular Lens for use after cataract surgery. It can be adjusted AFTER implantation in a patient. I was a founder of this firm which came out of University of California San Francisco (Dan Schwartz, M.D.) (originally named Calhoun Vision) many years ago.
Dr. Novack will be giving several presentations at the Annual Meeting of the American Academy of Ophthalmology in New Orleans in November 2017. On 9 November, he will lead a breakfast with FDA at the OIS AAO. On 11 November, he will give a talk at the Glaucoma Sub-specialty day on New Molecules in Glaucoma Development. On 14 November, he will give a talk on “An update on newly FDA-approved drugs and new drugs in clinical trials” at the Prevent Blindness America symposium. Finally, he will be part of a course on “Empowering glaucoma patients to take better care of themselves.”
Dr. Novack is giving a number of presentations at the upcoming American Academy of Ophthalmology annual meeting in New Orleans. On 9 November, he will chair a breakfast session at [email protected]. On 11 November, he will be presenting “New Molecules in Clinical Development” at the Glaucoma sub-specialty day. On 14 November, he will be presenting a talk on “Newly FDA-approved drugs and new drugs in clinical trials” in a glaucoma meeting sponsored by Prevent Blindness America. Also on 14 November, he will be part of a group of distinguished faculty teaching a course on “Empowering glaucoma patients to take better care of themselves”.
The Dry Eye Workshop II (DEWS II) report, sponsored by the Tear Film and Ocular Surface Society, has now been published in the July 2017 issue of The Ocular Surface. There is an introduction, and 10 sub-committee reports, including the Clinical Trials and Regulatory Sub-Committee report of which Dr. Novack was the chair. This represents over 2 years work by 125+ worldwide researchers and clinicians. It supplants the 2007 report with the latest review of Dry Eye research. #TFOSDEWSII @aao_ophth
Dr. Novack provided an update on novel therapies in pharmacotherapies in Ophthalmology Times. He reviews treatments in all phases of clinical development, and those recently approved. This is from anterior (dry eye, glaucoma) to posterior (wet AMD, etc).