Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

US FDA Postmarketing Drug Safety Modernization Plan Will Cut Across Review Disciplines

Executive Summary

Detection of nitrosamine impurities in some marketed drugs highlights need for standardized, consistent approach to systematically monitor risks of drugs throughout their lifecycles, CDER’s Janet Woodcock says. Safety monitoring overhaul is lagging behind new drug review modernization effort, but implementation is expected to begin in 2020.

You may also be interested in...



Postmarket Safety Signal Evaluation: US FDA ‘MAPPS’ Out New Approach

For drug sponsors, FDA's revised process could mean more public disclosures about potential safety risks and more regulatory actions to address those risks. CDER seeks to better leverage scientific and regulatory expertise, including in product quality and compliance, in investigating safety signals under the new policy manual, which also includes target timelines for action.

Global Scare Over Nitrosamine Impurities Extends To Diabetes Medication

Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.

US FDA Office Of New Drugs Reorg: Phase 3 Pushed To January

The FDA has confirmed the picks to head most of the new offices in the restructured drug review organization, with one notable exception. The choice for the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine is still pending, while one candidate ­– Hylton Joffe – will be serving as acting OND deputy director.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS141336

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