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.

Menu

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
Menu
My View
  • Edit
  • Add your favourite topics for quick access
Meet the Team
Ask the Analyst
Partnered Content
PDF Library
RSS Feeds
Subscribe
FAQs
Advertising
Report Store
UsernamePublicRestriction
Tags:
BioPharmaceutical United States Advisory Committees

FDA Biosimilar Assessment For Sandoz Filgrastim: From ‘Same’ To ‘Highly Similar’

  • News

Executive Summary

Agency reviewers show Oncologic Drugs Advisory Committee how analytical characterization can limit need for clinical studies.

You may also be interested in...



COVID-19 Vaccine Distribution Confusion Grows As Eligibility Widens

President-Elect Biden also adds David Kessler and Andy Slavitt to his COVID-19 response team, retains Francis Collins at NIH director.

Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Biden COVID-19 Plan Would Grow Domestic Manufacturing Base

The proposal, which would increase capacity for pandemic supplies, is similar to ideas President Trump embraced pre-pandemic.

Table

View full table

Topics

Related Companies

Tags:
BioPharmaceutical United States Advisory Committees
UsernamePublicRestriction

Register

PS063835

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

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