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…

Generic Drug Consulting More Relevant Now Than Ever

Generic Safety Surveillance, Pharmacovigilance and Labeling Consulting Could Be More Relevant Now than Ever

Regulatory Affairs, Research & Development

PDG™ is comprised of pharmaceutical consultants who devote considerable resources to brand and generic post-marketing safety surveillance, pharmacovigilance and labeling supplements. On August 29, 2011, Public Citizen filed a Citizen Petition calling for FDA to authorize ANDA holders to change approved generic labeling using the Changes Being Effected (CBE) and Prior-Approval Supplement (PAS) procedures (among…