Navigation Links
American Society of Hematology Statement on House Passage of Prescription Drug User Fee Act (PDUFA)
Date:5/31/2012

WASHINGTON, May 31, 2012 /PRNewswire-USNewswire/ -- Today the House passed H.R. 5651, 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 country's recent spate of shortages 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 House bill helps address drug shortages, the Society is concerned that it specifically exempts products derived from human plasma proteins and recombinant products replacing human tissue – products used for the treatment of hemophilia and other bleeding disorders – from the early reporting mandate in the legislation. ASH is currently working to ensure that 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 recommenda     tions 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 of current FDA requirements on shortages, and provide economic incentives to manufacturers of critical drugs.
'/>"/>

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:10/22/2014)... Oct. 22, 2014  Regulus Therapeutics Inc. ... company leading the discovery and development of ... it has demonstrated human proof-of-concept with a ... evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting ... C virus infection ("HCV").  Interim results from ...
(Date:10/20/2014)...  Indianapolis interventional medical device maker NICO ... 3D visualization leader Synaptive Medical announced ... Meeting that they have joined forces to integrate ... is the first of its kind and will ... NICO,s BrainPath® interventional access technology and Synaptive,s BrightMatter™ ...
(Date:10/20/2014)... --  BioNano Genomics announced today achievement of a major ... data at 30X depth, sufficient for a genome map, in ... established and demonstrated for the IrysChip TM V2, the ... and will be rolled out to BioNano,s collaborators and customers ... advancement at the American Society for Human Genetics (ASHG) ...
Breaking Medicine Technology:A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 2A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 3A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 4A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 5A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 6A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 7A Single Subcutaneous Dose of 2mg/kg of RG-101, Regulus' Wholly-Owned, GalNac-Conjugated anti-miR Targeting microRNA-122, Demonstrates 4.1 log10 Mean Viral Load Reduction as Monotherapy at Day 29 in Patients with Varied HCV Genotypes and Treatment H 8Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 2Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 3Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 4Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 5BioNano Genomics Announces One Human : One Chip : One Day 2BioNano Genomics Announces One Human : One Chip : One Day 3
... Arno Therapeutics, Inc., a clinical-stage biopharmaceutical company focused ... Food and Drug Administration ("FDA") accepted the Company,s ... of AR-12, a potentially first-in-class, orally available, PDK1 ... the endoplasmic reticulum stress pathway. Acceptance of ...
... ValueOptions(R), Inc., the nation,s largest ... support for the use of The Joint Commission,s ... basis for the recently completed pilot program was ... to help patients receive the most appropriate and ...
Cached Medicine Technology:FDA Accepts Arno Therapeutics' IND for AR-12 a PDK1 Inhibitor That Blocks the PI3K/Akt Pathway 2FDA Accepts Arno Therapeutics' IND for AR-12 a PDK1 Inhibitor That Blocks the PI3K/Akt Pathway 3ValueOptions(R) Supports New Hospital-Based Performance Measures to Help Patients Get the Best Treatment for Inpatient and Outpatient Services 2
(Date:10/22/2014)... 22, 2014 For Dr. Iris Hunter, a ... it’s an extension of her life’s mission. Her extensive experience ... the owner of FirstLight HomeCare, make it clear that Hunter’s ... me that my work makes a difference in the lives ... spirit, so after much research, I felt ready to start ...
(Date:10/22/2014)... Hay House is pleased to announce the official ... Life (Paperback; $10.82) written by the highly esteemed Tommy Rosen, ... book is meant to help readers of all kinds end ... , Recovery 2.0 is not the average self-help book, or ... guide for what comes next. For many, Alcoholics ...
(Date:10/22/2014)... Losing Weight Your Body’s Way , In a ... the face, it certainly can be difficult to choose the ... extra favor by doing it the healthy way? Set aside ... to your body, exercise regularly, and choose foods with the ... weight; you need to exercise more and eat less. Despite ...
(Date:10/22/2014)... Steven Reinberg HealthDay Reporter ... who quickly add weight and length may be showing a ... In adults, certain genes have been linked to increased ... gains in fat and lean muscle, the researchers said. ... and taller. By ages 2 and 3, however, these genes ...
(Date:10/22/2014)... 21, 2014 (HealthDay News) -- Measures taken by Firestone ... Ebola-ravaged Liberia may have limited the spread of the ... The Firestone Natural Rubber Co. provides health services ... of nearby densely populated communities. Between Aug. 1 ... Ebola cases among those 80,000 people. That incidence rate ...
Breaking Medicine News(10 mins):Health News:Dr. Iris Hunter to Host Grand Opening of FirstLight HomeCare Tomorrow 2Health News:Hay House Announces The Official Release of Recovery 2.0: Move Beyond Addiction and Upgrade Your Life 2Health News:Hay House Announces The Official Release of Recovery 2.0: Move Beyond Addiction and Upgrade Your Life 3Health News:ReductionGuruMD Presents Ways to Improve Your Weight Loss Results 2Health News:Tall, Heavy 1-Year-Olds May Be at Risk for Obesity Later, Study Finds 2Health News:Tire Company Sets Standard for Ebola Care in Liberia: CDC 2
... VEENENDAAL, the Netherlands, September 3 , ... for the First Half Year , ... results over the first half year of 2009. Despite challenging,global ... Net sales amounted to EUR 51.2 ...
... , CORAL GABLES, Fla., Sept. 2 Catalyst ... from The NASDAQ Stock Market to transfer the listing of its common ... transfer will be effective at the opening of the market on September ... no impact on the ability of investors to trade the stock. , ...
... , , WASHINGTON, Sept. 2 ... today to President Obama inviting him to address a Joint Session of Congress on ... the text of the letter to the President: , , ... House , Washington, D.C. 20500 , , Dear Mr. President: , ...
... , , ATLANTA, Sept. 2 ... GTIV ), a leading provider of comprehensive home health services, announced ... Inc. (d/b/a Magna Home Health), a part of the Rush Health ... was funded from Gentiva,s existing cash reserves. , , ...
... , , WASHINGTON, Sept. ... President, Campaign for Tobacco-Free Kids: , , (Logo: ... have taken decisive action to protect the state,s kids and taxpayers from ... by $1 to $3.00 per pack, making it the second highest state ...
... basal cell carcinomas responded to treatment , WEDNESDAY, Sept. ... off the so-called "Hedgehog" pathway beat back tumors in more ... type of skin cancer. , The drug also helped a ... brain cancer in children. , "We were both pleased and ...
Cached Medicine News:Health News:Nucletron Increases Full Year Outlook After Strong First Half 2009 2Health News:Catalyst Pharmaceutical Partners To Transfer To NASDAQ Capital Market 2Health News:Gentiva(R) Health Services Completes Acquisition of Home Health Agency 2Health News:Gentiva(R) Health Services Completes Acquisition of Home Health Agency 3Health News:Connecticut Cigarette Tax Increase Delivers Victory for Kids and Taxpayers; $1 Increase Gives State Second Highest Cigarette Tax in the Nation 2Health News:Connecticut Cigarette Tax Increase Delivers Victory for Kids and Taxpayers; $1 Increase Gives State Second Highest Cigarette Tax in the Nation 3Health News:New Compound Shrinks Skin Cancers 2Health News:New Compound Shrinks Skin Cancers 3Health News:New Compound Shrinks Skin Cancers 4
... Open heart surgery is no longer ... septal defects in young children and in ... care providers are seeking non-surgical options to ... Occluder is a permanently implanted prosthesis and ...
... Network (NLTN) is a training system sponsored ... (APHL) and the Centers for Disease Control ... in a variety of formats and offers ... Library. Log on to www.nltn.org for a ...
... Testing and Quality Assurance (for Waived and ... POLs, clinics and small hospitals maintain laboratory ... of patient lab results and assist labs ... opportunity to earn 12 P.A.C.E. Contact hours ...
An indirect immunofluorescence (IFA) antibody test for the detection and semiquantitation of anti-glomerular basement membrane (GBM) antibodies in human serum. Slide Detail: 6-well Monkey Kidney Subs...
Medicine Products: