Pink Sheet 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

US FDA Adds Generic Insights On How To Demonstrate Nanomaterials Quality

Executive Summary

Document sets final framework for assessing chemistry, manufacturing, controls and bioequivalence of a wide range of nanomaterials with new advice such as focusing analysis on the right therapeutic moiety.

You may also be interested in...



Messy Rules For Non‐Biological Complex Drugs Under Fire

Calls are mounting for the EU to make the centralized procedure mandatory for follow-on versions of non‐biological complex drugs and for better regulatory alignment with the US and other countries.

Nanomaterials In Drugs To Get Risk-Based Oversight

US FDA draft guidance advises manufacturers to use 11 risk factors in evaluating the use of nanomaterials in drug products. It also urges manufacturers to pay close attention to excipients.

Pink Sheet Podcast: FDA User Fee Bill Mark-Up, Postmarket Quality Requirements, Fewer Adcom Meetings

Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.

Topics

UsernamePublicRestriction

Register

PS146083

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