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

US FDA And OMB Should ‘Pause’ Billion-Dollar Quality Metrics Program, Industry Groups Say

Executive Summary

High projected cost and low perceived benefit merits further dialogue on US FDA's quality metrics initiative, industry coalition says. One group might tap into Trump administration's anti-regulatory view in advising budget office that compliance could cost industry $1bn per year. Groups question whether initiative could wind up causing drug shortages instead of preventing them.

You may also be interested in...



US FDA Launches Quality Maturity Pilots That Reward High-Performing OTC, Rx Manufacturers

One pilot target domestic manufacturers of finished drugs and another foreign manufacturers of APIs. As an incentive to participate, companies assigned high scores will be accorded regulatory flexibility. Also, participants that disclose facility ratings could “benefit from a competitive advantage.”

US FDA Launches Quality Maturity Pilot Program That Rewards High-Performing Manufacturers

High ratings on factors like quality culture could yield post-approval change flexibility for participating drug product and API manufacturing facilities.

US FDA Contracting Update: From Rating Site Quality Maturity To Blocking COVID-19 Scams

Contracts in works also would help track APIs, promote gene therapy standards, improve drug compounding, help extend shelf lives for US stockpile products and improve budget execution.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS120339

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