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 Struggles To Meet Goals As Drug Sponsors' Meeting Requests Rise

Executive Summary

The FDA did not expect to meet many FY 2018 goals for on-time scheduling of formal PDUFA meetings or issuing written responses in lieu of meetings.

You may also be interested in...



US FDA’s Cavazzoni Says Retaining Virtual Meetings Could Improve Communications Going Forward

One of the lessons learned from the pandemic may be that virtual meetings can be used in place of an in-person session more often.

The COVID Boom: CBER Receives More INDs in One Quarter Than The Previous 30 Combined

Bubble was short-lived, but still could create workload problems for the US FDA as it navigates the end of the coronavirus pandemic.

PDUFA VII: US FDA Says Money Can’t Solve Meeting Problems

Mid-cycle meeting for some supplements cannot be accommodated without extending the goal date, the agency tells industry negotiators.

Related Content

Topics

UsernamePublicRestriction

Register

PS140844

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