Navigation Links
FDA Requests Input on Development of User Fee Program for Biosimilar and Interchangeable Biological Products
Date:5/9/2011

SILVER SPRING, Md., May 9, 2011 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration is requesting input from stakeholders and the public relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications.  

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Biological products are produced in a living system such as a microorganism, plant, or animal cell, while small molecule drugs are typically made through chemical synthesis.

The Biologics Price Competition and Innovation Act of 2009, a provision of the Affordable Care Act, creates an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to, or interchangeable with an FDA-licensed biological product. It directs the FDA to develop recommendations for a 351(k) user fee program for fiscal years 2013 through 2017. The recommendations must be presented to Congress by January 15, 2012.

In addition to accepting written comments, the agency will consult with a range of groups, including scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and regulated industry. The FDA will take this input into account in developing proposed recommendations that will be published in the Federal Register for public comment, presented to Congressional committee staff, and presented at a public meeting.

A Federal Register notice, displayed today, describes the principles the FDA proposes to develop a user fee program, a proposed structure for the program, and proposed performance goals. The FDA is requesting public comment on each of these proposals, and is also posing several questions for public input. The notice also includes instructions for submitting comments and information for public and industry stakeholders who are interested in participating in meetings related to the development of recommendations for the 351(k) user fee program. The notice is available at http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm

For more information:

Biologics Price Competition and Innovation Act of 2009

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/UCM215031

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. After the ABRF Conference: Gene Codes Flooded with Requests for Early Access to NextGen Software Tools
2. ASEBIO Requests the Alignment of Spain With the European Unions Future Strategy of Bioeconomy
3. MONITORING FORCE GmbH Requests Acknowledgment of Flibanserin as "Orphan Drug"
4. GeoVax Labs Requests pre-IND Meeting With FDA
5. Stemedica Requests Pre-IND Meeting With FDA
6. The West Michigan Science & Technology Initiative is Named Statewide Reviewer for Life Science Funding Requests Through New Program
7. Xmark Requests That Icagen Oust Its CEO and Pursue Strategic Alternatives, and Calls on Board Members to Resign
8. Biotechnology Value Fund, L.P. Requests Avigen Board to Provide Critical Information to Stockholders
9. deCODE Requests Hearing With Nasdaq Following Receipt of Staff Determination Letter
10. CRAiLAR® Organic Fibers is Approved for Global Organic Textile Standard Chemical Input Certification
11. Pharmacyclics Reports Recent Developments and Financial Results for Fiscal Third Quarter 2011
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/9/2016)... ... 09, 2016 , ... With a presidential election in November and the future ... bring together over 500 top healthcare leaders for a night and day of debates ... by MBA students of the University of Pennsylvania’s Wharton School, will be held February ...
(Date:2/9/2016)... ... 2016 , ... Tunnell Consulting, Inc. announced that Frédéric Lefebvre has joined the ... acquiring new accounts and work closely with existing Tunnell clients throughout Europe to ensure ... European clients more than 15 years of experience in the pharmaceutical industry, a thorough ...
(Date:2/9/2016)... NEW YORK , Feb. 9, 2016 ... market analyzes the current and future prospects of the ... of this report include companies engaged in the manufacture ... comprises an executive summary with a market snapshot providing ... the scope of this report. This section also provides ...
(Date:2/8/2016)... - BIOREM Inc. (TSXV: BRM) ("Biorem" or "the Company") today ... technology companies in the TSX Venture 50 TM . ... the TSX Venture Exchange, in each of five major industry ... & life sciences, diversified industries and technology – based on ... investment, market cap growth, trading volume and analyst coverage. All ...
Breaking Biology Technology:
(Date:2/4/2016)... 4, 2016 The field of Human ... the most popular hubs of the biotechnology industry. ... huge studies of human microbiota, have garnered a ... the microbiome space has literally exploded in terms ... This report focuses on biomedical aspects of research, ...
(Date:2/3/2016)... http://www.researchandmarkets.com/research/d8zjcd/emotion_detection ) ... "Emotion Detection and Recognition Market by Technology ... Tools (Facial Expression, Voice Recognition and Others), ... Global forecast to 2020" report to ... ) has announced the addition of the ...
(Date:2/2/2016)... 2, 2016 Technology Enhancements Accelerate Growth of X-ray ... the digital and computed radiography markets in ... Indonesia (TIM). It provides an ... as well as regional market drivers and restraints. The ... penetration and market attractiveness, both for digital and computed ...
Breaking Biology News(10 mins):