Generics Bulletin 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 Refuses To Budge On Nitrosamines Compliance

Despite Complaints Of Possible Drug Shortages

Executive Summary

Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.

You may also be interested in...



US FDA Gives Industry An Extension On Nitrosamine Risk Assessments

Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.

US FDA Expectations For Removing Nitrosamines From All APIs, Drug Products

Agency guidance establishes process for ridding unsafe levels of the probable carcinogens from the pharmaceutical supply chain.

US FDA Limits GMP Exemption For ‘N of 1’ Investigational New Drugs

Agency drafts guidance on how to apply requirements for chemistry, manufacturing and controls, and for good manufacturing practices, to bespoke antisense nucleotides.

Topics

UsernamePublicRestriction

Register

GB151122

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