Navigation Links
American Society of Hematology Statement on Senate Passage of Prescription Drug User Fee Act (PDUFA)
Date:5/24/2012

WASHINGTON, May 24, 2012 /PRNewswire-USNewswire/ -- Today the Senate passed S. 3187, its version of the Prescription Drug User Fee Act (PDUFA) legislation including important provisions to mitigate drug shortages, most notably mandating an early warning system for manufacturers. ASH is the world's largest professional society concerned with the causes and treatment of blood disorders, representing more than 14,000 members who specialize in blood cancers such as leukemia, lymphoma, and myeloma, as well as serious blood diseases such as hemophilia. The county's severe shortage of more than 200 drugs has particularly affected ASH member hematologists and their patients because many of the drugs most vulnerable to shortages – older, generic sterile injectables – are used to treat blood disorders.

While ASH believes the Senate bill represents a helpful first step toward addressing drug shortages, the Society is concerned that the Senate bill exempts biologics from all provisions, and is particularly disturbed that products derived from human plasma proteins and recombinant products replacing human tissue – products used for the treatment of hemophilia and other bleeding disorders – are specifically exempted from the early reporting mandate in the legislation. ASH is currently working to ensure that biologics, including human plasma protein derivatives and recombinant products are included in the final PDUFA legislation.

Over the past 18 months the Society has advocated for legislation to combat drug shortages.  ASH has made several recommendations on ways to prevent and mitigate shortages, including to: increase FDA authority, require that the Secretary disseminate information about drug shortages to patient and provider organizations, enhance inter and intra agency coordination on drug shortages, require that the Agency Strategic Plan consider the impact of drug shortages on research and clinical trials, examine the impact o
'/>"/>

SOURCE American Society of Hematology
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
2. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
3. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
4. Aspirin Named 8th World Wonder by Majority of Americans
5. MedImmunes Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study
6. American Heart Association Comment Saving Lives in Type 2 Diabetics: Could It Be as Easy as Lowering Blood Pressure?
7. TrialCheck(R) Cancer Clinical Trial Matching Interface to Debut on American Cancer Society Web Site
8. Hypertension: Journal of the American Heart Association Rapid Access Reports: Hispanics Hypertension Better Controlled With Equal Access to Care
9. Positive Results for NKTR-118 (oral PEG-naloxol) Presented at American Academy of Pain Management Meeting
10. Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers
11. New MIRCERA(R) Data Analyses to be Featured at the American Society of Nephrology Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... Cardinal Health will today name three of the nation,s ... Independent Pharmacy Best Practices Competition, during the company,s ... gatherings of independent pharmacists. The Best ... Ohio , Tennessee and ... implementing exceptionally creative methods that demonstrate how independent pharmacies ...
(Date:7/25/2014)... 2014  Solanbridge Group Inc (OTC: SLNX) is pleased ... in Buzznbrewz.com and the Letter of Intent issued on ... executed Purchase Agreement. Charles R. Shirley ... to have Mr. David Pecoraro and Buzznbrewz.com ... the private sector and developed a tremendous network of ...
(Date:7/25/2014)... , N.Y. and MEXICO CITY , ... today announced that PLM, a Latin American healthcare sciences ... to deliver medical information on conditions such as cancer ... can now access the most up-to-date information to deliver ... medical professionals is growing rapidly, with many relying on ...
Breaking Medicine Technology:Cardinal Health Announces Three Best Practice Winners for Leading Change in Community Pharmacy 2Cardinal Health Announces Three Best Practice Winners for Leading Change in Community Pharmacy 3Cardinal Health Announces Three Best Practice Winners for Leading Change in Community Pharmacy 4Cardinal Health Announces Three Best Practice Winners for Leading Change in Community Pharmacy 5Cardinal Health Announces Three Best Practice Winners for Leading Change in Community Pharmacy 6Solanbridge Group Inc Announces Acquisition of Buzznbrewz.com 2Healthcare Sciences Publisher PLM and IBM Speed Access to Medical Information to Deliver Better Patient Care with Mobile 2Healthcare Sciences Publisher PLM and IBM Speed Access to Medical Information to Deliver Better Patient Care with Mobile 3Healthcare Sciences Publisher PLM and IBM Speed Access to Medical Information to Deliver Better Patient Care with Mobile 4
... Nektar Therapeutics,(Nasdaq: NKTR ) announced ... its pipeline programs will be presented at ... months. These presentations will,highlight Nektar,s novel therapeutic ... central nervous system (CNS), which leverage Nektar,s,innovative ...
... Leading RSV,investigator Dr. John DeVincenzo has taken another ... bronchiolitis and pneumonia,according to the Centers for Disease Control. ... of hospitalization of infants in the US and,one of ... group., DeVincenzo is using the process of RNAi ...
Cached Medicine Technology:Nektar Therapeutics to Present Positive Data at Upcoming Medical and Scientific Meetings 2Nektar Therapeutics to Present Positive Data at Upcoming Medical and Scientific Meetings 3Nektar Therapeutics to Present Positive Data at Upcoming Medical and Scientific Meetings 4RSV Researcher Makes Gains in Finding Treatments 2
(Date:7/27/2014)... Bags underneath the eyes is one condition that ... are a range of new products now available from Internet ... eyes serum review that is now posted for adults to ... issues with baggy eyes and how the natural ingredients in ... guide also provides a detailed overview of the creams and ...
(Date:7/27/2014)... 27, 2014 Ticket Down is a ... Forum in Inglewood, California on November 15th. This Australian ... can expect to hear songs from this amazing album at the ... in Inglewood, California at The Forum will be released for sale ... a.m. today local time TicketDown.com. This popular secondary ticket exchange ...
(Date:7/27/2014)... University of Manchester have discovered why medication to treat asthma ... Nature Medicine , show that drugs widely used to ... , In the UK pneumonia, which is caused by an ... is more serious for babies, young children, the elderly, smokers ... than 5 million people in the UK are affected by ...
(Date:7/27/2014)... July 27, 2014 The North American ... estimated at $1570 million in 2014, and it is ... CAGR of 4.64%. The report incorporates the factors that ... expectations of growth rates and projected total expenditure. The ... the global markets. Apart from the general overview of ...
(Date:7/27/2014)... The European Agricultural Adjuvants Market report defines and segments ... of revenue. The agricultural adjuvants market in Europe is ... to $657.1 million by 2018, at a CAGR of ... TOC of the European Agricultural Adjuvants Market report, to ... also provides a glimpse of the segmentation in the ...
Breaking Medicine News(10 mins):Health News:Baggy Eyes Serum Review Posted for Men and Women at Cherry News Website 2Health News:5 Seconds of Summer Tickets at The Forum in Inglewood (Los Angeles), CA Now Available For Sale at Ticket Down 2Health News:Drugs used to treat lung disease work with the body clock 2Health News:North America Security and Surveillance Radar Market is Expected to Reach $2030 million in 2019 - New Report by MicroMarket Monitor 2Health News:North America Security and Surveillance Radar Market is Expected to Reach $2030 million in 2019 - New Report by MicroMarket Monitor 3Health News:North America Security and Surveillance Radar Market is Expected to Reach $2030 million in 2019 - New Report by MicroMarket Monitor 4Health News:North America Security and Surveillance Radar Market is Expected to Reach $2030 million in 2019 - New Report by MicroMarket Monitor 5Health News:Europe Agricultural Adjuvants Market is Expected to Reach $657.1 million in 2018 - New Report by MicroMarket Monitor 2Health News:Europe Agricultural Adjuvants Market is Expected to Reach $657.1 million in 2018 - New Report by MicroMarket Monitor 3Health News:Europe Agricultural Adjuvants Market is Expected to Reach $657.1 million in 2018 - New Report by MicroMarket Monitor 4Health News:Europe Agricultural Adjuvants Market is Expected to Reach $657.1 million in 2018 - New Report by MicroMarket Monitor 5
... The patent expiry of blockbuster molecules ... intense competition from generics. CEOs have had ... to maintain the growth of their organisation ... on the market for niche blockbuster drugs ...
... Peanut Field, Product Sampling March 4 and 5NEW YORK, Feb. ... up shop in Vanderbilt Hall in New York City,s Grand ... questions and give away samples of peanuts, peanut butter and ... efforts nationally to rebuild consumer confidence in products made with ...
... Feb. 25 HealthFitness Corporation (NYSE Alternext ... and productivity management solutions, will conduct a conference call ... and year ended December 31, 2008. The call is ... 2009.Participants can dial (888) 396-5640 or (706) 643-0580 to ...
... N.J., Feb. 25 Psychiatric ... one of the nation,s leading experts in the field ... director of psychiatric drug research at the R/D Clinical ... special interest in the therapeutic areas of depression and ...
... Center for Wellbeing today announced its Chopra en ... Spanish speakers seeking out the Center,s programs and ... and human empowerment.(Photo: http://www.newscom.com/cgi-bin/prnh/20080617/LATU012 )"In the ... I first had the idea to create a ...
... on the future of SBIR grants in Washington, DC as a means ... being explicitly excluded from NIH stimulus money. Federal reauthorization or a continuing ... ... 25, 2009 -- Looking for funding for small business ventures ...
Cached Medicine News:Health News:Market for Niche Blockbusters Promises an Attractive Future for Large Pharmaceutical Companies, Indicates Frost & Sullivan 2Health News:Market for Niche Blockbusters Promises an Attractive Future for Large Pharmaceutical Companies, Indicates Frost & Sullivan 3Health News:Market for Niche Blockbusters Promises an Attractive Future for Large Pharmaceutical Companies, Indicates Frost & Sullivan 4Health News:America's Peanut Farmers to Travel to New York City to Meet Consumers, Work to Rebuild Trust in All Things Peanut 2Health News:Psychiatric Congress 2009 Announces Rakesh Jain, MD, MPH, as Program Chair 2Health News:The Chopra Center Introduces Mind-body Health Programs for Spanish Speakers: Chopra en Espanol Connects Spanish Speakers Worldwide to Deepak Chopra and David Simon's Global Message of Wellness 2Health News:The Commercialization Funding Coach, Fred Patterson, Weighs In On SBIR Funding for Small Business Ventures in Wake of NIH Exclusion 2Health News:The Commercialization Funding Coach, Fred Patterson, Weighs In On SBIR Funding for Small Business Ventures in Wake of NIH Exclusion 3
... Field (PEMF) bone growth stimulation delivered by ... long bone and small bone nonunions. Physio-Stim ... brace, or clothing without lessening its effectiveness. ... compact, lightweight unit including success rates as ...
Our products, with carefully researched design features, are tailored to making arthroscopic and ligament reconstructive surgery more reproducible, easier, quicker and safer....
... Screws. Optimal screw design ... selection options. Robust threads ... and chamfered screw hub ... tissue fixation. Features a ...
Cannulated Interference Screws...
Medicine Products: