Medtech Insight 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
UsernamePublicRestriction

Next Step For FDA's 'Case For Quality'? 8 New Guidance Docs

This article was originally published in The Gray Sheet

Executive Summary

Device manufacturers and FDA investigators reported generally positive experiences with FDA’s "critical-to-quality" inspection pilot, but the agency has decided to shift the focus to producing eight new guidance documents to better suit the project’s mission.

You may also be interested in...



At The Intersection Of Quality And Metrics: What's Ahead In FDA’s Effort To More Objectively Measure Quality

Quality metrics are being developed by the US FDA to not only determine which medical device facilities to inspect next, but to also raise firms' overall approach to quality above baseline. In-process metrics work by the Medical Device Innovation Consortium will be used as the agency comes up with its own robust set of measurements. Meanwhile, FDA is gearing up for a new pilot program targeting 10-20 device manufacturers that will submit quality data to the agency; MDIC explains how to calculate its three quality metrics; and quality officials from Baxter, J&J and Stryker weigh in.

Pandemic Response In US Consumer Health Market: OTC Pain Relief And Cough/Cold Purchases

Pain relief product sales grew 27% and upper respiratory sales 35% for the week ended 7 March as consumers respond to COVID-19, according to Nielsen data noted in a Jefferies report on consumer health purchasing trends. Private label market share is up slightly, while OTC purchases continue primarily in conventional stores.

venBio Raises $394m To Fund Biopharmas Through Human Proof-Of-Concept

Managing partner Corey Goodman said venBio didn’t have trouble closing its fund, because the venture capital firm prepared its investors for an economic downturn months ago.

Topics

UsernamePublicRestriction

Register

MT034364

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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