Product Designation by the Office of Combination Products (OCP) – Perils
July 4th, 2011 by pravin_soni
Requesting product designation from the Office of Combination Products carries its risks, and occasionally it can lead to an undesirable outcome when the primary mode of action (PMoA) is not clear-cut. As indicated in the following post from the Hyman, Phelps & McNamara Law Blog, the Sponsor may occasionally have to resort to legal […]