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:9/21/2017)... (France) , ... (PRWEB) September 21, 2017 , ... ... an international scientific and technical congress to review the latest knowledge on these ... of prestigious international speakers will discuss the impact of Biostimulants on Plant Nutrition, ...
(Date:9/21/2017)... ... September 21, 2017 , ... ... this month, the response was swift and efficient thanks to the continuing efforts ... is made up of more than 50 stakeholders, including officials from area counties ...
(Date:9/20/2017)... (PRWEB) , ... September 20, 2017 , ... ... today that it has appointed Vishwas Paralkar to the role of chief scientific ... targeting technology. He will report to Cybrexa’s president and CEO, Per Hellsund. , ...
(Date:9/20/2017)... (PRWEB) , ... September 20, ... ... recently published findings of a study examining the effects of exoskeleton-assisted walking ... spinal cord injury (SCI). The article, "Neuromechanical adaptations during a robotic powered ...
Breaking Biology Technology:
(Date:4/4/2017)... , April 4, 2017   EyeLock LLC ... announced that the United States Patent and Trademark Office ... broadly covers the linking of an iris image with ... transaction) and represents the company,s 45 th issued ... patent is very timely given the multi-modal biometric capabilities ...
(Date:3/29/2017)...  higi, the health IT company that operates the ... , today announced a Series B investment from ... The new investment and acquisition accelerates higi,s strategy to ... population health activities through the collection and workflow integration ... collects and secures data today on behalf of over ...
(Date:3/23/2017)... PUNE, India , March 23, 2017 The report ... Equipment, Touchless Biometric), Industry, and Geography - Global Forecast to 2022", published by ... growing at a CAGR of 29.63% between 2017 and 2022. ... ... Logo ...
Breaking Biology News(10 mins):