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:2/6/2016)... ... February 06, 2016 , ... Contact:, Abby ... for Excellence in Education Sponsors Teacher Training Program , Bite of Science Dinner ... The Center for Excellence in Education (CEE) will sponsor a Bite of Science ...
(Date:2/5/2016)... On Thursday, February 11, 2-1-1 San ... health and disaster services, and the Community Information ... care coordination and service delivery for the community to ... to better connect service providers to the information they ... Diego has handled more than 2.5 million ...
(Date:2/4/2016)... ... February 04, 2016 , ... Morf Media ... announced an interactive FDA compliance training course, Writing Effective SOPs ... Society) accredited interactive course on Morf Playbook—now conveniently available on smartphones and PCs--provides ...
(Date:2/4/2016)... ... 04, 2016 , ... Shimadzu Scientific Instruments will showcase several ... and poster sessions, and present on the analysis of mycotoxins and medical cannabis ... to 10 at the Georgia World Congress Center in Atlanta, Georgia. , ...
Breaking Biology Technology:
(Date:2/1/2016)... 1, 2016  Today, the first day of American ... to develop a first of its kind workplace health ... Watson. In the first application of Watson ... IBM ), and Welltok will create a new offering ... cognitive analytics, delivered on Welltok,s health optimization platform. The ...
(Date:1/25/2016)... 2016  Glencoe Software, the world-leading supplier of image ... will provide the data management solution OMERO Plus for ... Photo - ... Phenotypic analysis measures the characteristics and behavior ... between states such as health and disease, the presence ...
(Date:1/20/2016)...   MedNet Solutions , an innovative SaaS-based eClinical ... research, is pleased to announce the attainment of record-setting ... result of the company,s laser focus on (and growing ... it,s comprehensive, easy-to-use and highly affordable cloud-based technology platform. ... MedNet growth achievements in 2015 include: , ...
Breaking Biology News(10 mins):