HBW 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

FDA Drug Detention Regulation Follows Devices Oversight Model

This article was originally published in The Tan Sheet

Executive Summary

A proposed rule implementing new FDASIA authority to administratively detain drugs believed to be adulterated or misbranded largely mirrors regulations already in place for medical devices, FDA says.

You may also be interested in...



FDA Could Publish Drug GMP Data To Nudge Manufacturing Improvements

Batch failure and other measures manufacturers commonly track could be aggregated into an industry-wide index FDA would use to help make inspection decisions. CDER compliance chief Howard Sklamberg says FDA wants more predictive measures to find quality issues, rather than lagging metrics such as recalls or adverse events.

FDA’s Rx Administrative Detention Reg Coming, But Not For A Little While

Agency asks for stakeholder comments in advance of issuing a proposed rule on its new authority to detain potentially misbranded or adulterated drugs found during inspections, which was among FDASIA-mandated supply chain security improvements.

Bipartisan Support Pushes FDA User Fee Bill One Step From Passage

The Senate is expected to vote this week on the bipartisan compromise of the FDA user fee and reform legislation, which the House overwhelmingly passed in a voice vote June 20. Senate review of the bill will coincide with the Supreme Court’s decision on the health care reform law.

Topics

UsernamePublicRestriction

Register

RS124407

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