regulatory

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... 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... read more

April 13, 2022

Reclassification of Ophthalmic Drugs, Part 2: The Rules Have Evolved?

Top Food and Drug Agency Regulatory Cases By: Cheryl L. Rowe-Rendleman, PhD The FDA adheres to the Federal Drug & Cosmetics (FD&C) act to decide whether a product should... read more

January 24, 2022

Reclassification of Ophthalmic Drugs: Are the Rules Evolving?

Top Food and Drug Regulatory Cases By: Cheryl L. Rowe-Rendleman, PhD The US Food and Drug Administration (FDA) adheres to the Federal Food Drug & Cosmetics (FD&C) act to... read more

What is the 505(b)(2) Regulatory Pathway? <br>What Industry and Bench Scientists Need to Know: Part 3 of 3

November 11, 2021

What is the 505(b)(2) Regulatory Pathway?
What Industry and Bench Scientists Need to Know: Part 3 of 3

How does one begin the process of opening an application for an Investigational New Drug (IND) under the 505(b)(2) New Drug Application (NDA) regulatory pathway? How can you be... read more