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

QUOTED. 21 November 2019. Ricki Chase.

Executive Summary

Device manufacturers often fall down when conducting process validation activities because they fail to continually monitor their processes, consultant and former FDA investigations branch director Ricki Chase says. See her comments here.

You may also be interested in...



Process Validation Can Be Problematic For Device-Makers. Here’s Why – And What Companies Can Do About It

Medical device manufacturers often stumble when conducting process validation activities. In this Q&A, former US FDA investigations branch director Ricki Chase explains what those hurdles are and offers tips to firms to make sure they’re on the road to compliance.

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.

Topics

UsernamePublicRestriction

Register

MT125924

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