Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Builds Quality Dashboard To Focus CMC Reviews And Inspections On Greatest Risks

Executive Summary

A dashboard tool US FDA is developing promises to liberate key information from the agency’s trove of CMC review documents, enabling greater consistency among reviews and a greater emphasis on the manufacturing issues that pose the greatest risks.

You may also be interested in...



FDA Relying More On Predictive Analytics To Help Monitor Quality Risks Of Sites During Pandemic

Analytics tool plays key role in helping agency oversee quality of 1,800 newly registered hand sanitizer facilities despite travel restrictions.

FDA’s Revised Quality Metrics Program: Voluntary Now, Mandatory Later

US FDA will establish mandatory quality metrics reporting through a formal rulemaking process that could take years. Meanwhile, a revised draft guidance lays out plans for voluntary quality metrics reporting that could begin by January 2018.

FDA Focuses ANDA Reviews on Basis of Risk

A risk-ranking pilot went so well that FDA’s Office of Generic Drugs has swiftly expanded use of the technique to help focus the attention of reviewers, swamped by GDUFA deadline-studded, QbD-packed ANDAs, on the quality issues that will have the greatest impact on patient safety.

Topics

UsernamePublicRestriction

Register

PS119439

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel