On This Page Date: October 7 – 8, 2024 Day1: Mon, Oct 7 12:00 PM – 5:00 PM ET Day2: Tue, Oct 8 8:00 AM – […]

FDA has ongoing assessment, surveillance, compliance and pharmaceutical quality efforts across every product area, and we will continue to work with drug manufacturers to ensure safe, […]

Action The U.S. Food and Drug Administration has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary artery disease (CAD) to evaluate […]

On September 27, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years […]

Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) Guidance for Industry Control of Nitrosamine Impurities in Human Drugs Guidance for Industry Subscribe for email […]

Is the Critical Path Innovation Meeting a PDUFA meeting? The main goal of the CPIM is a collaborative discussion about emerging science, tools and methods to […]

Reference #: FEI 1317759 Product: Drugs Recipient: Recipient Name Mr. Michael P. Borrello Recipient Title Executive VP of Operations Ultra Seal Corporation 521 Main St,New Paltz, […]

Delivery Method: Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Dennis P. Borrello Recipient Title President and CEO Ultra Seal Corporation 521 Main StreetNew Paltz, NY […]

Hello. In this presentation, I will discuss the Critical Path Innovation Meeting, otherwise known as CPIM,  program, including goals of the program, how to request a […]