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

Complex Generics Guidance: US FDA Aims To Alert Firms, As GAO Requested

Executive Summary

The US FDA says it's working to provide the type of notice generic drug firms told the General Accountability Office they want to receive whenever the agency plans to issue or revise product-specific guidance on complex generics. Surprise issuance causes setbacks for generic drug sponsors who must scramble to revise their applications accordingly, if they can.

You may also be interested in...



FDA Looks Ahead To Complex Product-Specific Guidances

The agency offers a glimpse of its regulatory agenda, although several have been carried over through multiple list updates.

Exploring the US FDA's Upcoming Complex Generic Product-Specific Guidance Lists

The agency offers a glimpse of its regulatory agenda, although several have been carried over through multiple list updates.

Complex Generic Approval Delays Getting Congressional Attention

US Energy and Commerce Committee leaders request data on complex generic approvals, guidances, saying additional changes may be needed for faster approvals.

Related Content

Topics

UsernamePublicRestriction

Register

PS122331

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