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

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.

Advertisement

Related Content

FDA Office That Guided PDUFA V Gets New Name Highlighting Its Strategic Role
On The Trail Of Biosimilar Disclosure Scofflaws: FTC To Watch For Anti-Competitive Issues
After Pirfenidone: Broad Competition To Bring First Therapy For Underlying Cause Of IPF To Market
Biosimilars Guidance On Interferon Beta From EMA Foreshadows Possible Joint EU/U.S. Approach
Biosimilar User Fee Program Stresses FDA/Sponsor Meetings Early And Often
ANDA User Fees Will Fund Public Relations-focused Studies On Palatability Of Generics
Biosimilars Pathway Dilemma: When Should Sponsors Pick (k) Before (a)?
FDA “Busy” With Biosimilars; Sponsors Already In Pre-IND Meetings
"Mega-UFA" Is Behind Schedule; Combined User Fee Bill Will Be Difficult, But Still Expected
Waxman Says Biosimilar Pathway Will Push Applicants To BLA

Topics

Advertisement
UsernamePublicRestriction

Register

PS073181

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

Cancel