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
UsernamePublicRestriction

FDA Meetings With Biosimilar Sponsors Aim To Make 351(k) Pathway OK

This article was originally published in The Pink Sheet Daily

Executive Summary

Short public meeting on the biosimilar user fee agreement suggests the proof will be in the scheduling.

You may also be interested in...



FDA Office That Guided PDUFA V Gets New Name Highlighting Its Strategic Role

Center for Drug Evaluation and Research’s Office of Planning and Informatics has been renamed the Office of Strategic Programs and is playing a major role in implementing FDA’s patient-focused drug development initiative.

On The Trail Of Biosimilar Disclosure Scofflaws: FTC To Watch For Anti-Competitive Issues

As FDA prepares for another public hearing on the pathway, FTC says the rules requiring biosimilar applicants to share information with their reference product competitors could lead to anti-competitive issues and may be an ongoing concern.

After Pirfenidone: Broad Competition To Bring First Therapy For Underlying Cause Of IPF To Market

In the latest in “The Pink Sheet”’s market snapshot series, InterMune continues to work on getting pirfenidone approved in the U.S., while several companies are developing next-stage therapies for IPF.

Related Content

Topics

UsernamePublicRestriction

Register

PS078529

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