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

How To Get A Meeting With FDA: Guidance Describes Formal Meetings For Biosimilars

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s fourth biosimilars-related guidance describes the formal meeting process for sponsors with products in development; the process will require extensive requests and information packages.

Advertisement

Related Content

Complex ANDAs: Early Meetings With FDA Can Generate Bonus Communication
FDA Making A Generic Case For Continuous Manufacturing
Biosimilars Reviews Could Be Extended Two Months In BsUFA II
Biosimilar Workload At FDA: Policy Development Far Exceeds Application Review
Biosimilar User Fee Negotiations Won't Start Until 2016
Biosimilar Meeting Requests Increase, But FDA Cancels Some For Lack Of Data
Biosimilar Podium Promotion: FDA Emphasizes Advantages Of Abbreviated Pathway
Biosimilar User Fee Meeting Schedule Allows FDA Data “Pre-Review”
FDA Sets Biosimilar Application Fees, But Is Silent On Volume Projections
Biosimilar Interchangeability: Stakeholders Want More FDA Guidance, Fewer Hurdles

Topics

Advertisement
UsernamePublicRestriction

Register

PS075468

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