Navigation Links
FDA: 35 Innovative New Drugs Approved in Fiscal Year 2011
Date:11/3/2011

legislative authority for PDUFA expires on Sept. 30, 2012.  

"Before the PDUFA program, American patients waited for new drugs long after they were available elsewhere," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "As a result of the user fee program, new drugs are rapidly available to patients in the United States while maintaining our high standards for safety and efficacy."

In October 2011, the FDA released a new plan, Driving Biomedical Innovation: Initiatives to Improve Products for Patients, to assist companies engaged in new product development, particularly smaller, entrepreneurial companies.

In a separate action, the agency also released a report this week on drug shortages, expanded its current actions to address the problem, and, at the direction of the President, will broaden early notification of drug shortages and work with the Department of Justice to prevent price gouging.

For information:  

Report on FY 2011 Innovative Drug Approvals
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm276385.htm

Driving Biomedical Innovation:  Initiatives to Improve Products for Patients
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm274333.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sandy Walsh, 301-796-4669, '/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Upstream Biosciences Acquires Innovative Platform Technology and Drug Candidates for Tropical Parasitic Diseases
2. NIST Awards $2 Million to Velcura Therapeutics, Inc. for Innovative Technology R&D - Dual-Action Therapies for Bone Disease
3. Oculus Innovative Sciences to Present at 4th Annual BIO InvestorForum Conference
4. Surgeons Develop Innovative Life-Saving Treatments to Correct Massive Bleeding in Trauma Patients
5. Raydiance Collaborates With Rutgers University and Nations Largest Tissue Bank to Develop Innovative Tissue Processing Approaches
6. YMed, Inc. Successfully Completes First Clinical Cases With Innovative VascuTraK(TM) II PTA Dilatation Catheter
7. Innovative Brain Scanning for Alzheimers Screening Unveiled
8. Gates Foundation Seeks Proposals for Innovative Global Health Research
9. In Blood Vessel Stents, Innovative Materials Allow Better Control, Delivery of Gene Therapy
10. Studies of an Innovative Catheter Ablation System for Atrial Fibrillation Reveal Excellent Outcomes, Safety Profile and Fast Procedure Times
11. CeNeRx BioPharma Finalizes Plans to Initiate Phase II Trials for Its Novel Antidepressant Agent Tyrima(TM) Using Innovative Brain Imaging Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/2/2015)...  SI-BONE, Inc., a medical device company that pioneered ... the sacroiliac (SI) joint with the iFuse Implant System ... have now been performed world wide utilizing more than ... iFuse procedure continues to grow and gain momentum with ... the United States and 17 countries ...
(Date:3/2/2015)... BETHESDA, Md. , March 2, 2015  Celimmune ... and preventing autoimmune diseases, announced today that it has ... from Amgen (NASDAQ: AMGN ). Under the ... rights to develop, manufacture and commercialize AMG 714 on ... Concurrently, Amgen has been granted an exclusive option to ...
(Date:3/2/2015)... ANGELES , March 2, 2015 ImmunoCellular Therapeutics, Ltd. ... financial results for the year ended December 31, 2014 on March ... conference call and webcast on Thursday, March 12, 2015, at 5:00 ... , President and CEO.   , ... dial-in: (631) 291-4544; conference code 92238648. , , , ...
Breaking Medicine Technology:SI-BONE, Inc. Announces 15,000 iFuse Procedure Milestone 2SI-BONE, Inc. Announces 15,000 iFuse Procedure Milestone 3Celimmune Announces Anti-IL-15 Antibody Licensing and Option Agreements with Amgen 2Celimmune Announces Anti-IL-15 Antibody Licensing and Option Agreements with Amgen 3ImmunoCellular Therapeutics to Report 2014 Financial Results on March 9, 2015; a Business Update Conference Call and Webcast is Scheduled for March 12, 2015 2
... JOSEPH, Mo., April 14, 2011 On Monday, April ... Veterinary cardiologists on the Mobile Dog Heart Health Tour ... free dog heart examinations at Seger Dog Park. ... to providing free heart health screenings, veterinarians will be ...
... GlaxoSmithKline (GSK) is committed to ensuring that consumers and ... alli is safe and effective when used as directed. ... locally in the gastro-intestinal tract. GSK continues to proactively ... relevant information with regulatory agencies. Since orlistat ...
Cached Medicine Technology:Veterinarians to Perform Free Dog Heart Health Screenings in Philadelphia on April 18 2Veterinarians to Perform Free Dog Heart Health Screenings in Philadelphia on April 18 3
(Date:3/2/2015)... 02, 2015 The Alliance for Bangladesh ... expert Mark Chubb to serve as chief safety officer. ... and training in Bangladesh and guide remediation efforts in ... “Mark will ensure that the Alliance continues to bring ... for Bangladesh garment workers,” said Alliance Independent Chair Ellen ...
(Date:3/2/2015)... Viejo, California (PRWEB) March 02, 2015 ... release of the TranStatic Volume 2 from Pixel Film Studios. ... transitions made exclusively for FCPX,” said Christina Austin, CEO of ... to have in any Final Cut Pro X editors toolbox.” ... scene to the next with media altering static scrambling effects ...
(Date:3/1/2015)... 2015 As residents and business ... Michael Burns and Carita Weaver, believe in supporting ... with the Southlake Chamber of Commerce, Carroll Independent ... recently launched a website for Southlake mayoral candidate ... communications tool for Hill’s campaign, the website combines ...
(Date:3/1/2015)... 2015 Adults who are not legally ... term or universal policies can now use the QuotesPros.com ... life insurance companies for single adults can now be ... http://quotespros.com/life-insurance.html . , The rate plans that nationwide agencies ... to a number of life protection policies. The term, ...
(Date:3/1/2015)... 2015 The number of transvaginal mesh ... past few weeks in two New Jersey litigations where ... the Firm announces. , A Case List updated ... Bergen County proceeding established for products manufactured by Johnson ... weeks earlier, when 90 fewer cases had been centralized. ...
Breaking Medicine News(10 mins):Health News:Alliance for Bangladesh Worker Safety Names New Chief Safety Officer 2Health News:Pixel Film Studios released the TranStatic Volume 2 plugin for Final Cut Pro X today 2Health News:Website Launched for Southlake, Texas Mayoral Candidate Laura Hill 2Health News:Best Life Insurance Companies for Single Adults Now Searchable at Insurance Website 2Health News:Bernstein Liebhard LLP Comments on Case List Growth in New Jersey Transvaginal Mesh Litigations, Where Firm Attorneys are Representing Hundreds 2Health News:Bernstein Liebhard LLP Comments on Case List Growth in New Jersey Transvaginal Mesh Litigations, Where Firm Attorneys are Representing Hundreds 3Health News:Bernstein Liebhard LLP Comments on Case List Growth in New Jersey Transvaginal Mesh Litigations, Where Firm Attorneys are Representing Hundreds 4
... on Finding Solutions to Healthcare Crisis Affecting Communities of ... Voices: Healthcare for the Underserved today announced the second ... to be held April 30 - May 1, 2009 ... The conference, themed "Strengthening Families During Incarceration and ...
... animal testing encouragingBELGRADE, Serbia, Feb. 2 /PRNewswire-FirstCall/ - ... announced the results of preliminary testing of a ... the use of a combination of drugs; ribavirin ... ribavirin and tiazofurin in combination attenuated or weakened ...
... surgery for acute shoulder dislocation may provide the best ... million children and adolescents participate in organized athletics and ... of shoulder injuries that occur in these young athletes ... to a paper published in the February 2009 issue ...
... U.S. Department of Health and Human Services (HHS) ... standards developed by the Healthcare Information Technology ... Specifications" - documents that harmonize and recommend the ... electronic health records and help support the nationwide ...
... of fibroblasts during development also promotes their ability to ... in the February 9, 2009 issue of the ... epithelial cells into fibroblast-like mesenchymal cells is a critical ... factor Snail1 induces this conversion (known as epithelialmesenchymal transition, ...
... An online survey of 1,888,physicians, medical group ... U.S. physician groups are eager to accept a ... incentives,designed to promote broader adoption of information technologies ... (Logo: http://www.newscom.com/cgi-bin/prnh/20081013/AQM041LOGO ) , ...
Cached Medicine News:Health News:Community Voices: Healthcare for the Underserved Announces Second Annual Freedom's Voice Conference and Awards Gala 2Health News:Community Voices: Healthcare for the Underserved Announces Second Annual Freedom's Voice Conference and Awards Gala 3Health News:Hard To Treat Diseases (HTDS) Announces Initial Research Results on Potential MS Therapy 2Health News:Immediate Orthopaedic Care Can Help Heal a Young Athlete's Shoulder 2Health News:Immediate Orthopaedic Care Can Help Heal a Young Athlete's Shoulder 3Health News:HHS Secretary Recognizes Products of HITSP Standards Work 2Health News:HHS Secretary Recognizes Products of HITSP Standards Work 3Health News:HHS Secretary Recognizes Products of HITSP Standards Work 4Health News:Fibroblasts invade at a snail's pace 2Health News:Allscripts Survey of Healthcare Professionals Demonstrates Potential Impact of Economic Stimulus Plan on Electronic Health Record Adoption 2Health News:Allscripts Survey of Healthcare Professionals Demonstrates Potential Impact of Economic Stimulus Plan on Electronic Health Record Adoption 3Health News:Allscripts Survey of Healthcare Professionals Demonstrates Potential Impact of Economic Stimulus Plan on Electronic Health Record Adoption 4Health News:Allscripts Survey of Healthcare Professionals Demonstrates Potential Impact of Economic Stimulus Plan on Electronic Health Record Adoption 5Health News:Allscripts Survey of Healthcare Professionals Demonstrates Potential Impact of Economic Stimulus Plan on Electronic Health Record Adoption 6Health News:Allscripts Survey of Healthcare Professionals Demonstrates Potential Impact of Economic Stimulus Plan on Electronic Health Record Adoption 7Health News:Allscripts Survey of Healthcare Professionals Demonstrates Potential Impact of Economic Stimulus Plan on Electronic Health Record Adoption 8Health News:Allscripts Survey of Healthcare Professionals Demonstrates Potential Impact of Economic Stimulus Plan on Electronic Health Record Adoption 9
... the pioneers of surgical lighting, including ... automatic reserve bulb, an integrated surgical ... sets the standard for advanced lighting ... our latest generation surgical light ...
... SimpliCT® is an interventional guidance device ... significantly improve the accuracy of computed ... to improving accuracy, SimpliCT® also has ... of CT-guided puncture procedures including biopsies ...
Flat tip, bare fiber, no cooling, polished SMA 905, 3 meters long. Sold in boxes of five. Each part is individually packaged in sterile Tyvek bags....
Get YAG laser performance from your diode laser. Our proprietary NA shift technology offers efficient coupling of low divergence fiber to high divergence lasers...
Medicine Products: