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 Scrutizes Process Risks After Finding Nitrosamines In ARBs

Executive Summary

There is a new focus in reviews and inspections where nitrosamines or other dangerous process-related impurities might form.

You may also be interested in...



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

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.

FDA: Key FY 2019 Warning Letter Trend Is Inadequate Testing For API Impurities

This year’s 89 warning letters so far hit API testing for nitrosamines, aseptic facility design, contaminated water, API traceability and more.

Contamination In Common OTC Antacid Adds To FDA's API Impurity Concerns

FDA assessing contamination of Rx and OTC H2 blocker ranitidine to determine steps it should take. The contaminant, NDMA, is dangerous when consumed in large quantities, but has been found in H2 blockers at levels that don't pose a risk, FDA says.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS140752

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