News & Analysis as of

Fees › Biosimilars

Goodwin

FDA Releases Biosimilar User Fee Act Rates for Fiscal Year 2022

Goodwin on

Last week, FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2022 fiscal year, which runs from October 1, 2021 through September 30, 2022. The FDA determined these rates pursuant to the Food and Drug...more

Goodwin

White House Releases Policy Statement Calling For Elimination Of Federal Funding For FDA’s Pre-Market Review Costs

Goodwin on

The White House released a statement of administration policy on July 12 in response to the House of Representatives passing H.R. 2430, a bill that would reauthorize the FDA’s user fee programs, including FDA’s biosimilar...more

McDermott Will & Emery

Draft Guidance Outlines Recommendations for Formal Meetings Between FDA and Biosimilar Sponsors and Applicants

McDermott Will & Emery on

The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological...more

3 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide