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


Biologics Transition 'Dead Zone' Could Be Eliminated Under US Senate Bill

Executive Summary

Discussion draft includes provision requiring completion of assessments of transitioning NDA applications filed by 23 September, even if review lasts beyond the official 2020 transition date.

You may also be interested in...

Senate Wants Priority Review For 'Deemed' Biologics Not Approved By Deadline

Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.

Mylan/Biocon Running Out Of Time To Get Insulin Approved Before US Transition

After second complete response letter, Mylan and Biocon have just over six months to resolve manufacturing issues and obtain full approval or face having to resubmit the insulin as a biologics license application.

Insulin Application Reviews Would Continue After March 2020 Under Senate Bill

Bill would change US FDA's approach to handling follow-on applications submitted under Section 505 once products become "deemed" as biologics 23 March 2020, and could amend a provision in the Senate HELP Committee's health care bill, which aligns with FDA policy.

Related Content


Latest Headlines
See All



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