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

CDER Pilot Program Offers Potential New Pathway For Approval Of Novel Pharmaceutical Excipients

Executive Summary

After decades without an approval pathway for excipients, FDA pilot program paves the way for innovation.

You may also be interested in...



US FDA Seeks Ability To Include More Inactive Ingredient, Excipient Info In Brand Labeling

Additions could help streamline generic development, Center for Drug Evaluation and Research Director Patrizia Cavazzoni says.

Industry Applauds US FDA Plans For Novel Excipients Review Pathway, But Urges Refinement

The FDA’s proposal to establish a separate review path for novel excipients draws industry plaudits and requests for fine-tuning.

US FDA Mulls Pilot To Examine Separate Review Pathway For Novel Excipients

Proposal could yield a bounty of new options for innovative drug delivery systems.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS144995

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