Pink Sheet is part of the Business Intelligence Division 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


FDA New Year’s Resolution: Guidances On Payor Communications, Biosimilarity

Executive Summary

Agency expects to issue 101 guidances in 2017, including those on REMS assessment, refusal to file NDA and BLA submissions, and amendments to ANDAs.


Related Content

Multiple Endpoints In Clinical Trials: US FDA Advises How To Avoid False Positives
Biologic Product Naming: US FDA Sticks With Suffixes ‘Devoid Of Meaning’
Generic Application Quality Showing Signs Of Improvement
The Evolution Of 21st Century Cures Legislation
Off-Label Communications: Industry, FDA Debate Role Of Peer Review
Complex ANDAs To Be Allowed Pre-Submission Product Meetings
Par Fights FDA Forfeiture Of Generic Colcrys Exclusivity
ANDAs Can Get Priority, Eight-Month Reviews Under User Fee Deal
Biosimilar User Fee Agreement Puts FDA On Hook For Delayed Guidances
FDA Finds Fault With Third Duchenne Muscular Dystrophy Drug Filing





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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