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 GDUFA. This will help reduce drug shortages and bring drugs to market faster. The legislation also allows the FDA to perform inspections on a risk basis, focusing on the facilities posing the greatest risk to drug safety.

BPTF is an industry trade group for manufacturers of active pharmaceutical ingredients, with the primary objective of seeking clarification of current regulatory requirements.

About BPTF
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate organization of SOCMA, is an industry trade organization for manufacturers of active pharmaceutical ingredients (APIs), their intermediates and excipients. 

Contact:
Christine Sanchez
Senior Manager, Public Relations & Media
(202) 721-4182
sanchezc@socma.com


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

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:1/24/2017)... For today, Stock-Callers.com scans the following Biotechnology companies: ... Inc. (NASDAQ: ALDR ), BioDelivery Sciences International Inc. ... EGLT ). These equities are part of the Healthcare ... , 2017, with the NYSE Health Care Index dropping about ... 500 also were down 0.3% as a group. These stocks ...
(Date:1/24/2017)... -- Laboratory Markets Limited has completed a comprehensive market ... both clinical and research laboratory settings. This study, which ... $6.8 billion and growing to $9.2 billion (CAGR of ... of mass spectrometry across more than 5,200 clinical and ... in the use of mass spectrometry in terms of ...
(Date:1/24/2017)... ArisGlobal, a leading provider of integrated, cloud-based ... latest version of its comprehensive clinical trial management software. ... and efficiently meet new compliance and submission requirements, improve ... file so that compliance is assured and transparency is ... ...
Breaking Medicine Technology:
(Date:1/24/2017)... Milford, PA (PRWEB) , ... January 24, 2017 ... ... their main product “Lacto-Freedom” was recently accepted as a Registered Trademark by the ... prevent others from using a similar name which could confuse consumers into thinking ...
(Date:1/24/2017)... , ... January 24, 2017 , ... ... to the semi-final round of the 2017 Cupid's Cup Entrepreneurship Competition. Chaired by ... 12th year in 2017. The entrepreneurs will showcase their businesses on February 6, ...
(Date:1/24/2017)... ... January 24, 2017 , ... OMI Industries, a worldwide ... a distribution partnership with Byers Scientific & Manufacturing , a leading designer, ... the agreement, OMI Industries formulated a special version of Ecosorb® for Byers Scientific ...
(Date:1/24/2017)... (PRWEB) , ... January 24, 2017 , ... Center ... 21st century leadership, has named Hector M. Chavez, Manager, Employee & Labor Relations at ... center - as its Hispanic Leader of the Month. City of Hope is committed ...
(Date:1/24/2017)... , ... January 24, 2017 , ... The University of ... taken great care to design a program that provides teachers with the specific skills ... This online teaching certificate is ideal for post-baccalaureate students and HigherEducation.com is working to ...
Breaking Medicine News(10 mins):