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

Abuse-Deterrence Among New GDUFA Regulatory Science Priorities

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA says it will need tools to evaluate technologies designed to deter nasal abuse in generics.

You may also be interested in...



US FDA's Generic Research Projects Appear To Be Opening Way For ANDAs

Pre-ANDA meeting requests were high in some product categories where FDA conducted research projects, suggesting agency may influence sponsors' development priorities.

US FDA's Generic Research Projects Appear To Be Opening Way For ANDAs

Pre-ANDA meeting requests were high in some product categories where FDA conducted research projects, suggesting agency may influence sponsors' development priorities.

Drug Shortage Prevention Could Be Funded Through GDUFA

GPhA recommends FDA deploy user fee research money to look at shortage risk assessment and mitigation strategies, while the trade group continues to look for a product to fit its own shortage prediction model.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS076578

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