Blog

Meet Dr. Cheryl Rowe-Rendleman: A Trailblazer in Ophthalmic Research and Regulatory Consulting

In the fast-paced world of drug and device development, having a seasoned expert to navigate the complex regulatory landscape... read more

July 31, 2024

FORE the Ladies: Ophthalmology Charity Event Encourages Professional Women to Golf

Author: Shivani Majmudar, MSJ Golf traditionally has been regarded as “a man’s game,” that is hard to break into... read more

March 19, 2024

Regulatory

Data information and disclosurePart 3 Author: Dr. Cheryl L. Rowe-Rendleman Some exciting new changes were announced in 2023 that affect both drugs and Biologics. In the United States, “biologics”... read more

November 30, 2023

Conducting Clinical Trials

Part 2Author: Dr. Cheryl L. Rowe-Rendleman In the United States, “biological products” are subject to a different premarket pathway and differing intellectual property protections than products regulated as “drugs”.... read more

October 16, 2023

Obtaining Early Regulatory Advice — INTERACT Meetings

Part 1Author: Dr. Cheryl L. Rowe-Rendleman In the United States, “biologic products” are subject to a different premarket pathway than products regulated as “drugs”. This 3-part blog series describes... read more