in 2016, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for marketing authorization. Of these 27 were “new active substances” and 17 had an orphan designation. There were 2 negative opinions, which later went on to receive a positive opinion. None of the approvals were for ophthalmic products.
Dr. Novack was a featured speaker at the International Symposium on Ocular Pharmacology & Therapeutics in Rome, Italy in December 2016 (http://www.isoptclinical.com/). He presented 4 talks, including a review of outcomes in ophthalmic product development. The latter was part of a symposium with senior representatives of the FDA and EMA.
Dr. Novack presented the findings of the Clinical Trials and Regulatory sub-committee of the TFOS Dry Eye Workshop II at the Tear Film & Ocular Surface Society in Montpellier, France
Dr. Novack was invited to speak at the European Glaucoma Society meeting in Copenhagen in June 2012 on the issue of generic drugs.