10.20.2020

Office of Generic Drugs | Offices and Divisions

Generic Drugs Offices and Divisions
10.20.2020

Fledgling Indiana CDMO Incog plots first injectables manufacturing facility

Fledgling Indiana CDMO Incog plots first injectables manufacturing facility kblankenship Mon, 10/19/2020 - 22:48
10.19.2020

Good vibrations: ETH Zurich scientists tap ultrasound for targeted drug delivery to the brain

Good vibrations: ETH Zurich scientists tap ultrasound for targeted drug delivery to the brain fkansteiner Mon, 10/19/2020 - 17:42
10.19.2020

Safely Using Hand Sanitizer

You can help stop the spread of COVID-19 disease by washing your hands with soap and water for 20 seconds every time. If soap and water are not available, alcohol-based hand sanitizers can be used if they contain at least 60% alcohol and are used properly.
10.19.2020

It’s a Good Time to Get Your Flu Vaccine

Haven’t had your flu shot yet? It’s not too late. And there are still good reasons to get one.
10.19.2020

CDER Small Business & Industry Assistance (SBIA)

This site visit program is designed to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as the challenges that impact a drug’s developmental program and commercial life cycle. The goal of these visits is to provide OPQ staff exposure to the drug development and manufacturing processes in industry; therefore, a tour of pharmaceutical company facilities in operational status is an integral part of the experience.
10.19.2020

New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment - 10/15/2020 - 10/16/2020

New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment
10.19.2020

FDA Voices on Policy

FDA Voices on Policy
10.19.2020

The Logistics of COVID-19 Vaccine Trials

The Logistics of COVID-19 Vaccine Trials ahyler Mon, 10/19/2020 - 11:22
10.19.2020

PDUFA VII: Fiscal Years 2023 – 2027

Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products.