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

FDA wants faster compliance

This article was originally published in The Silver Sheet

Executive Summary

Companies must speed up responses to regulatory problems, CDRH Office of Compliance Director Tim Ulatowski said at the 2009 Parenteral Drug Association/FDA Joint Regulatory Conference, held Sept. 14-18 in Washington, D.C. "Today is a new day at FDA," Ulatowski said. "The commissioner's message is very plain, very clear." When it comes to product recalls, "the press release goes [out] today. The action is taken today," he said. "Industry has to get up to the speed that the agency is now working. Otherwise, you're going to be totally shocked at the response you're getting over the phone or in person from us.

You may also be interested in...



Industry, Agencies Are Making COVID-19 Partnerships Easy

Organizations like BARDA, CEPI and others are looking to partner with industry to rapidly test, manufacture, package and deploy vaccines and therapeutics, identifying areas they want to work together during BIO’s recent summit.

COVID-19 Economic Fallout May Delay Cell And Gene Therapy Reimbursement Solutions

The economic stress on payers caused by the pandemic will cause a setback in the development of payment approaches for regenerative therapy, Blue Cross Blue Shield executive warns.

US Medicare Agency Alters Payments For Use Of Telehealth Tech, Lab Specimen Collection For COVID-19

An interim final rule posted by the CMS this week widens further a series of telehealth exemptions and lab specimen collection payment provisions it has previously issued to help providers during the COVID-19 pandemic.

Topics

UsernamePublicRestriction

Register

MT036398

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