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
'/>"/>

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

Page: 1 2

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:1/22/2015)... PRINCETON, N.J. , Jan. 22, 2015  Derma ... tissue regeneration company focused on advanced wound care, ... from placental tissues, have been added to the ... announcement increases the opportunity for the AMNIOEXCEL® and ...
(Date:12/24/2014)... NEW YORK , Dec. 24, 2014 PlasmaTech Biopharmaceuticals, ... in critical areas, announced the closing of an underwritten public ... purchase up to an aggregate 3,500,000 shares of common stock, ... per warrant.  The warrants have a per share exercise price ...
(Date:12/24/2014)... December 23, 2014 “Preparative & ... HPLC, Flash), Consumables (Columns, Solvents, Buffers, Valves, Guages, ... & Agriculture) - Forecasts to 2019” provides a ... opportunities, current market trends, and strategies impacting the ...
(Date:12/24/2014)... SoundConnect’s 2015 next generation ... communication technology, provide continued education and inform users ... demonstrates online communication features and benefits; empowering users ... innovative and powerful tools. , According to SoundConnect’s ...
Breaking Biology Technology:Derma Sciences Expands Access of its AMNIOTIC TISSUE Product Line with New Premier, Inc. Agreement 2Derma Sciences Expands Access of its AMNIOTIC TISSUE Product Line with New Premier, Inc. Agreement 3Derma Sciences Expands Access of its AMNIOTIC TISSUE Product Line with New Premier, Inc. Agreement 4Derma Sciences Expands Access of its AMNIOTIC TISSUE Product Line with New Premier, Inc. Agreement 5PlasmaTech Biopharmaceuticals, Inc. Announces Closing of Public Offering 2PlasmaTech Biopharmaceuticals, Inc. Announces Closing of Public Offering 3Preparative and Process Chromatography Market is expected to reach $9 billion by 2019 - New Report by Marketsandmarkets 2Preparative and Process Chromatography Market is expected to reach $9 billion by 2019 - New Report by Marketsandmarkets 3Preparative and Process Chromatography Market is expected to reach $9 billion by 2019 - New Report by Marketsandmarkets 4SoundConnect Launches Leading Edge Business Communications Webinar Series 2SoundConnect Launches Leading Edge Business Communications Webinar Series 3
... 2 Matthew B. Wiener, PharmD, Chief,Executive Officer ... Leadership Award from the Colorado Cancer Coalition. The ... development of the Just-In-Time (JIT),enrollment methodology for cancer ... the evening of October 6th, at the St. ...
... Scheduled for Monday, October 6, 2008 at ... 2 ARCA biopharma, Inc., a,biopharmaceutical company ... cardiovascular diseases, today announced that,Richard Brewer, the ... Michael Bristow, M.D., ARCA,s chairman and chief ...
... Blood and Marrow Stem Cell,Transplantation Program at the ... is the first in the United States to ... from The,Joint Commission, the nation,s leading accrediting agency ... Transplantation Program also,recently became the first and only ...
Cached Biology Technology:Matthew B. Wiener, CEO of Pharmatech, Inc., Is Awarded the Cancer Leadership Award From the Colorado Cancer Coalition 2ARCA biopharma to Present at JMP Securities Healthcare Focus Conference 2ARCA biopharma to Present at JMP Securities Healthcare Focus Conference 3ARCA biopharma to Present at JMP Securities Healthcare Focus Conference 4ARCA biopharma to Present at JMP Securities Healthcare Focus Conference 5Stem Cell Transplantation Program at Hackensack University Medical Center: First in Nation to Receive Joint Commission Certification for Quality and First in New Jersey to be Named a Blue Distinction(R) Center for Specialty Care. 2Stem Cell Transplantation Program at Hackensack University Medical Center: First in Nation to Receive Joint Commission Certification for Quality and First in New Jersey to be Named a Blue Distinction(R) Center for Specialty Care. 3
(Date:12/17/2014)... 2014 Research and Markets ( http://www.researchandmarkets.com/research/s6qzt5/samsung_galaxy_s5 ) ... S5 - Home Button Synaptics Fingerprint Sensor Technology Analysis" ... http://photos.prnewswire.com/prnh/20130307/600769 Based on a totally ... for the first time a fingerprint sensor in its ...
(Date:12/17/2014)... Valencell, a leader in performance biometric data sensor technology, ... such as Intel, Jabra, Atlas, and Scosche to develop ... products will be showcased at CES 2015, taking place ... "Our partners choose PerformTek biometrics, because ...
(Date:12/15/2014)... and Markets ( http://www.researchandmarkets.com/research/87pph8/global_facial ) has announced ... 2015-2019" report to their offering. ... a technology used for the identification of individuals. Facial ... person such as nose, jaw edges, mouth, and the ...
Breaking Biology News(10 mins):Samsung Galaxy S5 - Home Button Synaptics Fingerprint Sensor Technology Analysis 2Valencell PerformTek Biometrics Power the Most Accurate Wearables at CES 2015 2Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 2Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 3
... (Feb. 19, 2007) X-rays have been used for ... at the U.S. Department of Energys (DOE) Argonne National ... technique that can take images of ultra-small structures buried ... cells such as cellular nuclei. Argonne scientists along ...
... challenges of distinguishing one nano-sized probe image from another ... researchers at Georgia Tech and Emory University made an ... a lot like a starry sky on a clear ... already made great strides in solving a problem very ...
... is at the center of some of the nation,s ... to global climate change. To provide a critical overview ... a summit of leading energy experts from the government, ... inform an Academies study under way called "America,s Energy ...
Cached Biology News:Lensless camera uses X-rays to view nanoscale materials and biological specimens 2Lensless camera uses X-rays to view nanoscale materials and biological specimens 3Astronomy technology brings nanoparticle probes into sharper focus 2Astronomy technology brings nanoparticle probes into sharper focus 3NAS to hold 2-day summit on energy issues 2
Gloves are 9.25 long, latex, powder free, smooth and ambidextrous....
Lipid-rich bovine serum albumin for cell culture. It is chromatographically purified and has an IgG content 1.0% (w/w)....
Request Info...
Prepared with distilled water. Yeast extract solution is autolyzed at 150 g/L....
Biology Products: