Lead article on FDA regulation of ophthalmic drugs

Dr. Novack published the lead article in the June 2024 issue of the American Journal of Ophthalmology. In this article, he showed a time line of key U.S. FDA registration and the availability of ocular hypotensive drugs (i.e., drugs that decrease elevated intraocular pressure) to patients and their doctors. He concludes that “Concomitant with public health events, the laws that the US Congress enacted in response to these events, as well as increasing scientific standards have been increased magnitude and quality of the
clinical data used to support the these now sterile, stable, safe, and effective drug products into our therapeutic pharmacopeia, while providing rapid review of NDAs.

AJO cover June 2024
About Dr. Novack

Dr. Gary Novack is a board-certified clinical pharmacologist and President of PharmaLogic Development with more than 40 years of experience in ophthalmic drug development, clinical research, and FDA regulatory strategy.

He has consulted for over 100 pharmaceutical and medical device companies and authored more than 400 scientific publications.

Contact Dr. Novack
Contact Dr. Novack