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

Upcoming Meetings: FDA design control meeting

This article was originally published in The Gray Sheet

Executive Summary

FDA design control meeting: Open public meeting to provide a "mid-course" assessment of the agency's design control inspection program will take place at 8:30 a.m. on Feb. 2 at the National Institutes of Health's Natcher Auditorium in Bethesda, Maryland. FDA will present results of its analysis of Design Control Inspectional Strategy Reports gathered during the first six months of the one-year "transition" period preceding enforcement of the quality system regulation's design control requirements on June 1, 1998. The agency also will seek input from device industry reps and other interested parties on topics such as the adequacy of guidance for industry or field investigators...

You may also be interested in...



IPO Year In Review: Record-Year Bodes Well For 2021, And For More SPACs

Biopharma was an attractive investment in 2020 and fundamentals are unchanged in 2021, including the pandemic’s work-at-home requirements, which allowed more companies to go public faster.

Abbott Capitalizes On Pandemic Testing Boom; Device Sales Stay Almost Flat

Abbott reported almost 28% revenue growth in the fourth quarter led by the exploding demand for COVID-19 tests and continued success of its FreeStyle Libre continuous glucose monitor.

Agios’ Mitapivat Shows Improvement In Regularly Transfused PKD Patients

While representing a smaller population, the ACTIVATE-T trial targeted patients seen as having greater unmet need.

UsernamePublicRestriction

Register

OM013202

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