In Vivo 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

For Device Companies, Are FDA Headaches Ahead?

Executive Summary

Guidant Corp.'s failure to get an approval recommendation on July 10 from the FDA's Circulatory Systems Device panel for its Contak CD/Easytrak system to treat congestive heart failure certainly wasn't bad news for other players in cardiac rhythm management (CRM). But for those companies that don't compete directly with Guidant in CRM--and perhaps even for those that do--the push-back by the FDA panel raised some eyebrows. It's entirely possible that the Guidant device simply didn't measure up--that the panel was correct in judging that it didn't meet the clinical end-points required to recommend approval. But some device industry executives worry about the future direction of the FDA's approval process.

You may also be interested in...



‘Supplement’ On CBD Product Label A Bullseye For US Litigants, Says Attorney

Two CBD marketers warned by FDA in a recent crackdown are targeted in class action complaints alleging they made unsubstantiated health claims and mislabeled ‘illegal drug’ products as supplements. Complaints are a wake-up call to CBD wellness industry to ensure claims are substantiated, as the class action bar is on the prowl following the agency’s 15 warning letter blast in November.

HBW Market News: GNC US Chief, Clasado Commercial Head, Barentz Funding

GNC hires Josh Burris as chief US officer; Clasado BioSciences adds Bellchambers as commercial director; and Barentz plans expansion with Cinven investment.

US Government Drug Pricing ‘Negotiation:’ Where We Go From Here

The House passage of a Democratic bill authorizing the federal government to negotiate drug prices in Medicare has sharpened the debate over how prices feed innovation, but the underlying policy stands little chance of being enacted without a Democratic wave in the next election. Pink Sheet's table highlights the key provisions of HR 3 and other pending pricing legislation.

Topics

Related Companies

UsernamePublicRestriction

Register

IV001705

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