When to Change Prescription Drug Labeling

When to Change Prescription Drug Labeling?

Labeling / Marketing, Pharmaceutical Consulting News, Regulatory Affairs, Safety & Pharmacovigilance

You don’t have to be a prescription drug labeling consultant to realize that a case series of serious events in the literature, FDA safety alert, FDA labeling change notification letter, or other new safety information should prompt a review of drug product labeling (aka package insert). That is not what this paper is about. This…

FDA Expedited Programs

FDA Expedited Programs for Drug Development and Review, Explained

Pharmaceutical Consulting News, Regulatory Affairs, Research & Development

It has been my experience that even the most experienced drug development and pharmaceutical consultants will stumble over the definitions of, and differences between FDA’s four expedited programs. Included among them are accelerated approval, priority review, fast track, and breakthrough therapy.[1] This paper is designed as a primer to increase understanding of the expedited programs,…