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

US combination office stalled pending procedural steps

This article was originally published in Clinica

Executive Summary

Setting up the FDA's new office of combination products within the commissioner's office in December 2002 was the agency's first step towards putting the new user fee bill in place. But the office will not be fully operational until the FDA can draft regulations spelling out certain office procedures, according to its first director, Mark Kramer.

You may also be interested in...



QUOTED. 3 April 2020. Minetta Liu.

Liquid biopsy start-up Grail Inc. announced that a study of almost 6,700 participants found that its blood test could detect more than 50 types of cancer with a low false-positive rate. See what Minetta Liu, study co-lead author and a Mayo Clinic professor of oncology, had to say about the research.

Colorectal, Bladder Cancer Therapies Are Top Prospects For April US FDA Approvals

Sanofi’s next-generation meningococcal vaccine, broader use of Bristol-Myers Squibb’s Reblozyl move toward approval; United Therapeutics foreshadows Trevyent regulatory difficulties.

Rapid Biopharma Response To COVID-19 Enabled By Decades Of R&D Investment, Firms Say

Biopharma is working on a reputation renaissance as the public looks to industry for treatments and vaccines for the COVID-19 epidemic and drug pricing concerns take a back seat.

Topics

UsernamePublicRestriction

Register

MT061384

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