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:7/25/2014)... , July 25, 2014  The Chemistry, ... Tobago Ministry of Health approved the introduction of ... increases the cure rate from Hepatitis C, and ... genotype 1 virus. Telaprevir is available in ... INCIVO®. Photo - http://www2.prnewswire.com.br/imgs/pub/2014-07-25/original/2026.jpg   ...
(Date:7/25/2014)... , July 25, 2014 According ... Research "Global and China Insulin Market (Rapid-Acting, Short-Acting, Intermediate-Acting, ... Size, Share, Growth, Trends and Forecast (Value and Volume), ... at USD 19.99 billion in 2012 and is expected ... to 2019 to reach USD 32.24 billion in 2019. ...
(Date:7/25/2014)...  AMETEK, Inc. (NYSE: AME ) today ... as Vice President and General Manager, Engineered Medical Components, ... "I am pleased that Kurt has joined ... experience, especially in the medical device industry, and we ... growth and success of our medical components businesses," commented ...
Breaking Medicine Technology:The Hepatitis C virus is the main cause of liver transplant in the world 2The Hepatitis C virus is the main cause of liver transplant in the world 3Global Insulin Market Expected to Reach USD 32.24 Billion Globally in 2019: Transparency Market Research 2Global Insulin Market Expected to Reach USD 32.24 Billion Globally in 2019: Transparency Market Research 3Global Insulin Market Expected to Reach USD 32.24 Billion Globally in 2019: Transparency Market Research 4AMETEK Names Kurtis L. Goos, Vice President & General Manager, Engineered Medical Components 2
... Jan. 18, 2011 MKS Instruments, Inc. (Nasdaq: ... processes and improve productivity, today announced that it will release ... close on Wednesday, February 2, 2011.  A conference call with ... 8:30 a.m. (eastern time). The call will be broadcast live ...
... DW Healthcare Partners (DWHP), a leading private equity ... of Bradley Lanham as the new Chief Executive Officer ... completed acquisitions of institutional pharmacies specializing in long term ... Utah, Idaho and Colorado. "Brad,s appointment as ...
Cached Medicine Technology:DW Healthcare Partners Announces New CEO on Heels of Increased Investment in Institutional Pharmacy Sector 2
(Date:7/26/2014)... July 26, 2014 As the ... the true vision of Xoçai is ... its exclusive and healthy chocolate products. One such ... of cacao, açaí berries and blueberries, an ingredient ... high-antioxidant blend is utilized in all of Xoçai ...
(Date:7/25/2014)... 2014 2014 Deep Research Report ... Industry” is a professional and in-depth research ... market. The report provides basic Laser Scanning ... Microscope definition, classification, application, and industry chain ... covers international market analysis, including China’s domestic market ...
(Date:7/25/2014)... 2014 As reported by the Statesman Journal ... Heroin (7/20), police in Salem, MA as well as ... the recent heroin epidemic that has taken many lives during ... heroin-related overdose case in which police were able to make ... phone. By pretending to be the victim and claiming to ...
(Date:7/25/2014)... America (GSA) the nation,s largest interdisciplinary ... has chosen Heather M. Young, PhD, RN, FAAN, ... 2014 recipient of the Doris Schwartz Gerontological Nursing ... GSA,s Health Sciences Section, is given to a ... and sustained contribution to gerontological nursing research. , ...
(Date:7/25/2014)... Florida Hospital and MOSI officially announced a transformational partnership ... come and make a difference in the Tampa Bay community. ... to provide the support needed to keep the science center ... the IMAX Dome Theatre from film to a state-of-the-art digital ... Theatre in the state of Florida, and it is one ...
Breaking Medicine News(10 mins):Health News:Xocai-Asia Japanese Distributors in Hachioji, Japan Sanction Local Single-Source-Chocolate Investigative Report: MXI-Corp-Asia Discloses Direct-Sales Compensation Plan 2Health News:Xocai-Asia Japanese Distributors in Hachioji, Japan Sanction Local Single-Source-Chocolate Investigative Report: MXI-Corp-Asia Discloses Direct-Sales Compensation Plan 3Health News:Xocai-Asia Japanese Distributors in Hachioji, Japan Sanction Local Single-Source-Chocolate Investigative Report: MXI-Corp-Asia Discloses Direct-Sales Compensation Plan 4Health News:Laser Scanning Confocal Microscope Market: 2014 Global, China Manufacturing Bases Analysis Now at DeepResearchReports.com 2Health News:Laser Scanning Confocal Microscope Market: 2014 Global, China Manufacturing Bases Analysis Now at DeepResearchReports.com 3Health News:Laser Scanning Confocal Microscope Market: 2014 Global, China Manufacturing Bases Analysis Now at DeepResearchReports.com 4Health News:Multiple States Crack Down on Heroin Epidemic 2Health News:Young earns GSA's 2014 Doris Schwartz Gerontological Nursing Research Award 2Health News:Florida Hospital Donates a Two Million Dollar Transformational Gift to the Museum of Science and Industry (MOSI) 2Health News:Florida Hospital Donates a Two Million Dollar Transformational Gift to the Museum of Science and Industry (MOSI) 3Health News:Florida Hospital Donates a Two Million Dollar Transformational Gift to the Museum of Science and Industry (MOSI) 4
... , ... keep a notebook of surgical cases on the iPhone or iPod touch. Pop up menu’s and ... the busy medical provider. , ... 3, 2009 -- I-Surgery , a new iPhone application for surgery, can be used by ...
... ... shown that sleep deprivation can raise blood pressure as well as increase the risk ... risks while increasing the quality of sleep. , ... Phoenix, AZ (Vocus) December 3, 2009 -- Two sleep ...
... ... anytime, anywhere, is now available. , ... (PRWEB) December 3, 2009 -- It still blazes across news channels, web sites and ... of H1N1 influenza A (swine flu) . Reports of vaccine shortages and long lines ...
... , , McALLEN, Texas, ... ENSG ), announced today that it has acquired three ... & Healthcare Center in McAllen, the 100-bed Alta Vista ... Rehabilitation & Healthcare in Harlingen. The acquisitions were effective ...
... GRAND RAPIDS, Mich., Dec. 3 Van Andel Research Institute ... acid (ABA) works at the molecular level to help plants ... Their findings, published in the journal Nature , could ... world and combat global food shortages. The findings could ...
... , NEW YORK, Dec. 2 Reportlinker.com ... its catalogue: , Renal Disease Treatments: Products and Therapies ... market in products and services, providing data for 2008 and ... annual growth rates (CAGRs) from 2009 to 2014 , ...
Cached Medicine News:Health News:Treadmill Desks Lower Health Risks Caused by Lack of Sleep 2Health News:Finally, Some Good News about Swine Flu 2Health News:The Ensign Group Acquires Three Texas Skilled Nursing Facilities 2Health News:The Ensign Group Acquires Three Texas Skilled Nursing Facilities 3Health News:VAI Researchers Find Long Awaited Key to Creating Drought Resistant Crops 2Health News:VAI Researchers Find Long Awaited Key to Creating Drought Resistant Crops 3Health News:VAI Researchers Find Long Awaited Key to Creating Drought Resistant Crops 4Health News:Reportlinker Adds Renal Disease Treatments: Products and Therapies 2Health News:Reportlinker Adds Renal Disease Treatments: Products and Therapies 3Health News:Reportlinker Adds Renal Disease Treatments: Products and Therapies 4Health News:Reportlinker Adds Renal Disease Treatments: Products and Therapies 5Health News:Reportlinker Adds Renal Disease Treatments: Products and Therapies 6Health News:Reportlinker Adds Renal Disease Treatments: Products and Therapies 7Health News:Reportlinker Adds Renal Disease Treatments: Products and Therapies 8Health News:Reportlinker Adds Renal Disease Treatments: Products and Therapies 9Health News:Reportlinker Adds Renal Disease Treatments: Products and Therapies 10
... minimal cervical spine manipulation. Prevent dental and ... Cost effective alternative to X-ray. Light-guided intubation ... soft tissues in the neck. This technique ... the trachea relative to the esophagus. A ...
Bivona® stylets are manufactured of malleable stainless steel wire. The length can be adjusted by sliding the attached silicone stopper. The Blue Line® tracheal tube introducer (bougie) is de...
... Aaron manufactures two groups of flexible lighting ... and non-sterile in three different sizes 5", ... shaft portion of the light). These lights ... light is needed., ,The second group ...
... manufactures two groups of flexible lighting products. ... non-sterile in three different sizes 5", 10", ... portion of the light). These lights are ... is needed., ,The second group of ...
Medicine Products: