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

510(k) "refuse-to-accept" rates vary from 3% to 28% depending on ODE division.

This article was originally published in The Gray Sheet

Executive Summary

510(K) "REFUSE-TO-ACCEPT" RATES RANGE FROM 3% TO 28% depending upon the division of the device center's Office of Device Evaluation, according to agency statistics. As of March 31, the Division of Cardiovascular, Respiratory, and Neurological Devices reported the highest refuse rate (28%) while the Division of Clinical Laboratory Devices checked in with the lowest (3%). The figures were compiled in response to House Commerce/Oversight Subcommittee Chairman Joe Barton's (R-Tex.) request for information on FDA's device review program ("The Gray Sheet" March 27, p. 9).

You may also be interested in...



Abbott Readying Vildagliptin ER In India Amid Price Competition

Abbott is developing an extended release version of vildagliptin in India, adding a new dimension to the market dynamics for the DPP-4 inhibitor, which has seen a key patent expire. Sustained release vildagliptin products from Wockhardt and Synokem also appear to be in the works.

AstraZeneca's Risky Lynparza Endpoint In Pancreatic Cancer Goes Before Advisory Cmte.

US FDA usually recommends using overall survival for pancreatic cancer drugs, but AstraZeneca choose progression-free survival; now ODAC will weigh in on whether the PARP inhibitor olaparib demonstrated a clinically meaningful impact. The firm cites enrollment and design challenges in the gBRCAm population as reasons for using PFS.

Did Sarepta Need To Tell Investors About Its Vyondys 53 Dispute Resolution Request?

Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.

UsernamePublicRestriction

Register

MT004039

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