Navigation Links
FDA Completes Work on Three Drug User Fee Programs
Date:1/13/2012

or differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. The proposed Biosimilar and Interchangeable Products User Fee program is intended for products approved under a new abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological product. The Affordable Care Act of 2010 contains a subtitle called the Biologics Price Competition and Innovation Act (BPCI) of 2009, which established this pathway.

Prior to it becoming law, competition in the biologic drug market was stifled. Enactment of BPCI will spark the development of a new segment of the industry, where companies will be able to develop alternative products. This will help spur innovation, improve consumer choice and drive down costs.

The recommended user fee program for biosimilars includes fees for products in development to generate revenue in the near-term and to provide FDA with the resources needed to support development-phase meetings with sponsors of biosimilar biological product candidates.

For more information:

User fees
http://www.fda.gov/ForIndustry/UserFees/default.htm

Prescription Drug User Fee Act
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm

Generic Drug User Fees
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm

Biosimilar and Interchangeable Products User Fees
http://www.fda.gov/ForIndustry/UserFees/ucm268124.htm

Media
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Respironics, Inc. Completes Voluntary Recall Notification of a Limited Number of Trilogy 100 Ventilators
2. Quest Diagnostics Completes Acquisition of S.E.D. Medical Laboratories
3. Elevation Pharmaceuticals Completes $30 Million Series B Financing to Advance Aerosol COPD Therapy
4. Weikang Bio-technology Group, Inc. Completes HQ Relocation After Purchasing Building for $14 Million and Answers Questions About its Third Quarter Financials
5. Orexigen® Therapeutics Completes Public Offering of Common Stock and Warrants to Purchase Common Stock
6. Valeant Pharmaceuticals Completes Acquisition of iNova
7. Valeant Pharmaceuticals Completes Acquisition of Dermik
8. Vermillion Completes the Acquisition of Correlogic Systems Ovarian Cancer Diagnostics Business
9. Perceptive Informatics Completes Over 500 System Integrations as the Biopharma Industry Continues to Adopt Seamless eClinical Solutions
10. Sotera Wireless Completes $12.2 Million Series D Financing, Signs Agreement with Cerner
11. Concord Medical Completes its Twelfth Annual Academic Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/3/2015)... 3, 2015 About cardiovascular ... involves narrowing or blockage of blood vessels. Cardiac ... smoking, high cholesterol, and high blood pressure. Coronary ... and heart failure are some of the major ... vessels, especially coronary arteries, is one of the ...
(Date:9/3/2015)...  WellCare Health Plans, Inc. (NYSE: WCG ) ... president and chief financial officer, is scheduled to present ... Wednesday, September 9, 2015, at 9:25 a.m. Eastern time. ... addition, a replay of the webcast will be available ... live broadcast and the replay will be available on ...
(Date:9/3/2015)... , Sept. 3, 2015 Research and ... the "Global Medical Devices Packaging Market - By ... Forecasts 2014 - 2020" report to their offering. ... market is driven directly by its end use industry, ... in the packaging of these devices so as to ...
Breaking Medicine Technology:Global Cardiovascular Implants Market 2015-2019 2Global Medical Devices Packaging Market 2015 - Market Trends and Forecasts to 2020 for the $21 Billion Industry 2Global Medical Devices Packaging Market 2015 - Market Trends and Forecasts to 2020 for the $21 Billion Industry 3Global Medical Devices Packaging Market 2015 - Market Trends and Forecasts to 2020 for the $21 Billion Industry 4Global Medical Devices Packaging Market 2015 - Market Trends and Forecasts to 2020 for the $21 Billion Industry 5Global Medical Devices Packaging Market 2015 - Market Trends and Forecasts to 2020 for the $21 Billion Industry 6Global Medical Devices Packaging Market 2015 - Market Trends and Forecasts to 2020 for the $21 Billion Industry 7Global Medical Devices Packaging Market 2015 - Market Trends and Forecasts to 2020 for the $21 Billion Industry 8
... , , BEDFORD, Mass. , ... fluorescence in vivo imaging from research through medicine, ... intellectual property portfolios and related technology platforms from Bayer Schering ... 45 issued patents worldwide covering a wide range of fluorescence ...
... FRANCISCO, Calif. , Jan. 28 iPierian, Inc., ... discovery and development through the application of cellular reprogramming, today ... Kingdom has issued a Notification of Grant to iPierian ... induced pluripotent stem cell (iPSC) technology. , The newly ...
Cached Medicine Technology:VisEn Acquires Key Fluorescence Agent Intellectual Property Portfolio and Technology Platforms From Bayer Schering Pharma 2First iPierian Patent for Induced Pluripotent Stem Cell Technology Granted by United Kingdom Intellectual Property Office 2First iPierian Patent for Induced Pluripotent Stem Cell Technology Granted by United Kingdom Intellectual Property Office 3
(Date:9/4/2015)... ... September 04, 2015 , ... Many consumers are looking for a quick and convenient ... solution. , The patent-pending K Med Cups provide a quick and simple way to brew ... a cold, flu or cough. As a result, they enhance comfort and health. The invention ...
(Date:9/4/2015)... ... September 04, 2015 , ... The conference ... in Hollywood, Florida October 9-10, 2015 at the Diplomat Resort & Spa has ... are doctors and researchers at the top of their field and will be ...
(Date:9/4/2015)... ... ... Lalonde Gordon ran a 44.64 seconds scorcher in the third and final ... meters final, with an impressive 44.89 seconds at the 2015 North American, Central American ... August 2015. The 44.64 time is a new NACAC Championship record. , Recent ...
(Date:9/4/2015)... ... ... Overseer at The House of Yahweh, has written an open letter to Pope Francis that ... States. , Yisrayl lays out what he says is the true meaning of the Pope’s ... the meaning of his own name and describes what bible prophecy says about his own ...
(Date:9/4/2015)... ... September 04, 2015 , ... Friday night, Chicago lovebirds Jenny ... Rescue’s A Night of Hope event supporting families affected by autism, raising nearly $250,000. ... Joe Salas, joined together at the Oscar Swan Inn to support the cause. ...
Breaking Medicine News(10 mins):Health News:Redesigned Packaging for Powdered Medicinal Mix Invented by InventHelp® Client (CBA-2637) 2Health News:Integrative Healthcare Symposium Focus On: The Microbiome Conference Program Announced 2Health News:Lalonde Gordon’s Recipe Brings Home the Gold 2Health News:Lalonde Gordon’s Recipe Brings Home the Gold 3Health News:Yisrayl Hawkins Writes Open Letter to Pope Francis In Light of Approaching U.S. Visit 2Health News:Jenny McCarthy & Donnie Wahlberg Help Raise Over $200,000 For Generation Rescue’s ‘Night Of Hope’ Chicago Charity Event 2
... Surgical,Company (Nasdaq: STAA ) today announced that it ... 28, 2008 on Tuesday, May 6, 2008,after the market ... webcast,on Tuesday, May 6, 2008 at 5:00 p.m. Eastern ... developments. The dial-in number for,the conference call is 866-250-3615 ...
... 24 Physicians Healthcare,Management Group, Inc. (Phyhealth) (Pink ... in partnership with physicians,today announced that Phyhealth Plan ... agreement with Advantica EyeCare to provide,comprehensive vision services ... in,the latter half of 2008., Mr. Robert ...
... Season are Those That Give Back and Support ... the Fight Against AIDS in Africa, NEW YORK, ... few weeks early at the INSPI(RED) Mothers,Brunch in New York City on ... Mya, and other (RED) supporters,to celebrate motherhood and to share the impact ...
... - Attorney Mark Werksman States ,Justice Was Served, -, ... Angeles City,Attorney,s Office dismissed a case against Yolanda McGriff, ... providing nursing and home,health care to a low-income, disabled ... while she was providing care,for her employer, a man ...
... The Department of,Justice announced today that the ... Andrew Bodnar, was indicted for his,role in lying ... involving the,popular blood-thinning drug, Plavix, used by heart ... the alleged illegal actions of Bodnar,related to the ...
... future research , , WEDNESDAY, April 23 (HealthDay News) -- ... disease appears to hasten progress of a related but ... new study. , The surprising findings, published in the ... Clinical Investigation , are significant, because individuals with frontotemporal ...
Cached Medicine News:Health News:STAAR Surgical Announces First Quarter 2008 Earnings Release Date and Conference Call 2Health News:Phyhealth Signs Agreement with Advantica EyeCare to Provide Vision Services for Pilot HMO 2Health News:Get INSPI(RED) This Mother's Day 2Health News:Get INSPI(RED) This Mother's Day 3Health News:Get INSPI(RED) This Mother's Day 4Health News:Case Dropped Against Healthcare Worker Who Was Arrested While Providing Care to an Elderly, Disabled Man in Los Angeles Home 2Health News:Former Bristol-Myers Squibb Senior Vice President Indicted for Lying to the Federal Government About Popular Blood-Thinning Drug 2Health News:Enzyme Beneficial to Alzheimer's Plays Darker Role in Other Dementia 2
A new generation of ORTHOMED S.A. fixation staples, manufactured from cobalt-chromium alloy: tried and test strength and tolerance...
The staple fixation system provides a simple means of attaching tissue to bone....
... Cement consists of a two ... bone cement liquid within a ... polyethylene bag,containing bone cement powder ... interiors of the blister pack,and ...
... Bone Cement consists of a ... containing bone cement liquid within ... sterile polyethylene bag,containing bone cement ... The interiors of the blister ...
Medicine Products: