Navigation Links
SOCMA's Bulk Pharmaceuticals Task Force Welcomes House Passage of FDA Reform Act
Date:5/31/2012

WASHINGTON, May 31, 2012 /PRNewswire-USNewswire/ -- Just days after the Senate overwhelming approved legislation to better protect the nation's drug supply, the House of Representatives today followed suit, passing the Food and Drug Administration Reform Act of 2012 (H.R. 5651) in a 387-5 vote. The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), welcomed the vote and urged House and Senate conferees to quickly agree on a final bill for the president's signature.

H.R. 5651 includes authorization of the Generic Drug User Fee Act (GDUFA), legislation that would improve the drug supply chain by requiring inspection of all foreign and domestic drug production facilities. BPTF, a key industry stakeholder, has advocated since 2006 for increased resources for the FDA to conduct more inspections of foreign drug ingredient manufacturers, and they worked with other industry groups last year to negotiate the terms included in GDUFA.

"With today's vote, the U.S. will make significant strides in ensuring that our drug supply is less susceptible to sub-par drugs from facilities with lax quality compliance standards," said BPTF Chair Patty Benson, Quality Assurance Director of SAFC. "We urge quick action by both House and Senate conferees to agree on a final bill that the president can sign as soon as possible."

The generic drug industry will pay approximately $1.5 billion over five years in return for faster and more predictable review of generic drug applications, according to the terms of
'/>"/>

SOURCE Society of Chemical Manufacturers and Affiliates
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Lexicon Pharmaceuticals to present at the Jefferies 2012 Global Healthcare Conference
2. Hybrid Fuels, Inc. Announces Name Change to Nouveau Life Pharmaceuticals, Inc.
3. AcelRx Pharmaceuticals Announces Pricing of a $10.0 Million PIPE Financing
4. Isis Pharmaceuticals to Present at the Goldman Sachs 33rd Annual Global Healthcare Conference
5. Auxilium Pharmaceuticals, Inc. to Present at the Goldman Sachs Global Healthcare Conference 2012
6. Vanda Pharmaceuticals to Present at the Jefferies 2012 Global Healthcare Conference
7. Cannabis Science Gets Set to Release "Phytiva" Its Newest Brand of Over-the-Counter Skin and Nutraceutical Product Lines Through its Newest Venture Phytiva Pharmaceuticals Inc.
8. Oramed Pharmaceuticals Granted Core Technology Patent in New Zealand
9. Syndax Pharmaceuticals to Present Updated Overall Survival Data With Entinostat in Metastatic Breast Cancer at ASCO
10. Avanir Pharmaceuticals to Present at Jefferies 2012 Global Healthcare Conference
11. Endo Announces Resolution of Patent Litigation with Watson Pharmaceuticals Related to Lidoderm®
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... MOUNTAIN VIEW, Calif. , Sept. 3, 2014 ... recently completed phase 2 placebo-controlled trial in pediatric ... a statistically significant increase in head circumference.  Decreased ... the disease. Rett syndrome is ... is usually diagnosed by 24 months of age. ...
(Date:9/2/2014)... , Sept. 2, 2014 Astellas has appointed ... property (IP) in the Americas. Kellerman will report directly ... general counsel at Astellas. In his new role, Kellerman ... with the business and manage the region,s intellectual property ... "I am very pleased to welcome Jim to ...
(Date:9/2/2014)... Reportlinker.com announces that a new market ... Asia-Pacific Infusion Therapy Device Market ... The Asia-Pacific ... pumps, syringe infusion pumps, disposable infusion pumps, IV ... are segmented based on the type of displacement ...
Breaking Medicine Technology:Edison Pharmaceuticals Announces Phase 2 Positive Clinical Results for EPI-743 in Rett Syndrome 2Edison Pharmaceuticals Announces Phase 2 Positive Clinical Results for EPI-743 in Rett Syndrome 3Leading Intellectual Property Counsel, James Kellerman, Joins Astellas as Vice President 2Asia-Pacific Infusion Therapy Device Market 2Asia-Pacific Infusion Therapy Device Market 3Asia-Pacific Infusion Therapy Device Market 4Asia-Pacific Infusion Therapy Device Market 5Asia-Pacific Infusion Therapy Device Market 6Asia-Pacific Infusion Therapy Device Market 7Asia-Pacific Infusion Therapy Device Market 8Asia-Pacific Infusion Therapy Device Market 9Asia-Pacific Infusion Therapy Device Market 10Asia-Pacific Infusion Therapy Device Market 11Asia-Pacific Infusion Therapy Device Market 12Asia-Pacific Infusion Therapy Device Market 13Asia-Pacific Infusion Therapy Device Market 14
... , , , , , , MUMBAI, India, Dec. ... IN, NSE: SUNPHARMA, BSE: 524715) today announced that Glass, Lewis ... that shareholders of Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF) ... of directors, including all of its nominees for election or ...
... , SUNNYVALE, Calif., Dec. 22 Arrayit Corporation (OTC Bulletin ... announced that the Company has made a technological breakthrough in ... microarrays, which are tiny glass substrates that contain rows and ... diagnostics. The advance allows highly precise printing of as many ...
Cached Medicine Technology:Glass Lewis Advises Taro Shareholders to Hold Taro's Board Accountable for Its Failures 2Glass Lewis Advises Taro Shareholders to Hold Taro's Board Accountable for Its Failures 3Glass Lewis Advises Taro Shareholders to Hold Taro's Board Accountable for Its Failures 4Arrayit Corporation Announces Manufacturing Breakthrough 2Arrayit Corporation Announces Manufacturing Breakthrough 3
(Date:9/3/2014)... An inspiring story of the importance ... the season finale of “Extreme Weight Loss” Season Four. ... daughter from Highlands Ranch, Colo. who have a strained ... pounds. Their challenge is to team up to lose ... non-competitive approach to weight loss transformations, “Extreme Weight Loss” ...
(Date:9/3/2014)... Tulsa, OK (PRWEB) September 03, 2014 ... in the sales, installation, and support of Sage 100 ... named a Sage North America Million Dollar Club achiever ... 2013-2014 business year. Sage recognizes CS3 Technology and all ... to the overall success of Sage, its business partners ...
(Date:9/3/2014)... Gorda, FL (PRWEB) September 03, 2014 ... healthcare delivery, increases patient safety, decreases medical errors, ... providers. , To mark the important role ... in America, IHS and others across the U.S. ... Technology (NHIT) Week , September 16-20, 2014. With ...
(Date:9/3/2014)... September 03, 2014 Immersion Active ... received a silver medal in the 2014 Content Marketing ... Marketing Awards is the leading awards program for people ... of every medium and strategic purpose. , Immersion ... developed for its client Home Instead Senior Care®. This ...
(Date:9/3/2014)... OR (PRWEB) September 03, 2014 ... the use of appropriate evidence-based health care along ... parties benefit from the expertise of accredited independent ... the health care system. , As a core ... IROs often settle questions of medical necessity. Yet ...
Breaking Medicine News(10 mins):Health News:“Extreme Weight Loss”: Jeff and Juliana’s Journey begin at the University of Colorado Anschutz Health and Wellness Center 2Health News:CS3 Technology Named a Sage Million Dollar Club Achiever for 2013-2014 2Health News:Innovative Healthcare Solutions (IHS) Celebrates National Health IT Week September, 15-19, 2014 2Health News:Immersion Active Wins Silver for Email Strategy in 2014 Content Marketing Awards 2Health News:Independent Review Expands Its Scope: Case Studies in Context 2Health News:Independent Review Expands Its Scope: Case Studies in Context 3
... Healthcare practitioners can increase the number of patients with heart ... cent, helping them to reduce their risk of dying and ... Munk Cardiac Centre. Previous studies, including one by ... a cardiac illness, such as a heart attack, can reduce ...
... Randy Dotinga HealthDay Reporter , MONDAY, Feb. ... Bull, AMP and Rockstar have no health value and ... review finds. The increasingly popular, highly caffeinated drinks ... hyperactivity disorder (ADHD) or other health or emotional problems, ...
... MONDAY, Feb. 14 (HealthDay News) -- Most medical devices recently ... life-threatening or serious safety risks were initially approved for use ... research reveals. The findings call out for an overhaul ... the market in the first place, said the study team, ...
... have a subtype that is characterized by high levels ... tends to be more aggressive than other breast cancer ... is so aggressive could aid in the development of ... researchers, led by Lewis Chodosh, at the University of ...
... , MONDAY, Feb. 14 (HealthDay News) -- ... Afghanistan and Iraq and who were evacuated due to ... military personnel to return to duty, new research shows. ... Department of Defense civilians -- account for about 50 ...
... / MEDai, a leading provider of advanced clinical analytic ... version of Pinpoint Review, its real-time, clinical surveillance system ... set of clinical watch triggers, expanded core measure alerts ... Stay Prediction and Mortality Prediction. "Hospitals are ...
Cached Medicine News:Health News:Heart patients should be referred to Cardiac Rehabilitation before leaving hospital 2Health News:Heart patients should be referred to Cardiac Rehabilitation before leaving hospital 3Health News:Energy Drinks May Hurt Kids: Study 2Health News:Energy Drinks May Hurt Kids: Study 3Health News:Report Blames Speedy FDA Clearance for Medical Device Recalls 2Health News:Report Blames Speedy FDA Clearance for Medical Device Recalls 3Health News:Nonmilitary More Likely to Return to War Zone After Psych Condition 2Health News:Elsevier/MEDai enhances real-time clinical surveillance system for hospitals 2
... Foot Control allows hands-free operation in nerve ... or 5.0 mA) with SoloStim provides a ... fine control when close to nerve., ... nerve block products, including the clinically proven ...
... ,The Centiva/5 Critical Care Ventilator is your solution ... critical care environment. The Centiva has been designed ... size with high levels of performance. The Centivas ... patients bed and allows you the freedom to ...
... Mesh Elastic is a lightweight and large pore ... mesh is able to adapt to all movements ... honeycomb like structure with the large pores enables ... The mesh is ideal for incisional hernia repair ...
... a mesh plug to treat large or ... hernias and femoralhernias. The self-expanding plug perfectly ... completely. Premilene Mesh Self-Forming Plug is a ... Mesh. The plug corresponds with all properties ...
Medicine Products: