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.
FDA continues to be open during government shut-down, due in part to user fees paid for by industry
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).
With recent press releases by the Sponsors, there are at least five ophthalmic New Drug Applications (NDAs) under review by the U.S. FDA at this time (25 April 2017). Some of these were held up for chemistry issues in their original 2016 submissions.