Navigation Links
NORD Calls Senate Bill Most Important Since Orphan Drug Act
Date:5/24/2012

o further qualify and categorize biomarkers for use in clinical trial design, including under Accelerated Approval and similar mechanisms
  • A new initiative to evaluate patient tolerance to risk of proposed therapies and to incorporate more patient input in the review process
  • Legislative provisions in the bill include:

    • Codification and modernization of the Accelerated Approval process
    • Improvements to policies governing conflicts of interest that will allow expert participation on FDA Advisory Committees
    • Creation of a new category of "breakthrough" therapies that will encourage early public and private collaboration to aid in clinical trial design and review
    • Expanded access to experts for rare diseases beyond the review process
    • Expansion of devices intended for use in very small patient populations, including the possibility of profit for such devices when used in adult populations

    The US House of Representatives is working on companion legislation (HR 5651 – the Food & Drug Administration Reform Act of 2012) that has already been unanimously approved by the Committee on Energy & Commerce in a similar bipartisan fashion.  Adoption of that measure is expected when the House resumes its session at the beginning of June.

    Both the House and Senate bills are the culmination of a process conducted every five years to reauthorize the Prescription Drug User Fee Act (PDUFA) and related legislation that provides critical funding to allow FDA to review potential new therapies in a timely manner.  As the voice of rare disease patients and their families in the U.S. since 1983, NORD has served as the primary representative of the rare disease patient community over the past two years as needs were prioritized and the legislation now being voted upon by the House and Senate was drafted.


    '/>"/>
    SOURCE National Organization for Rare Disorders (NORD)
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2

    Related medicine technology :

    1. American Fertility Association Calls for Expanded Research to Advance New Technology to Screen Embryos for Genetic Abnormalities
    2. American Meat Institute Calls WCRF Panel Recommendations on Meat Consumption Extreme and Unfounded
    3. Superbug Outbreak Calls for Immediate Increased Attention on Infection Control
    4. AIDS Vaccine Advocacy Coalition Calls for AIDS Vaccine Field to Work Together to Analyze STEP Study Data and Determine Best Course to Move Forward
    5. On World AIDS Day, CHF International Calls for Community Mobilization and Local Capacity Building to Fight HIV/AIDS
    6. New AVAC Report on Pre-Exposure Prophylaxis Calls for Immediate Planning to Anticipate Study Results of Potential New HIV Prevention Option
    7. Kroger Recalls Peanut Butter Bakery Cookies and Select Cakes Due to Possible Health Risk
    8. Christie Cookie Recalls Certain Lots of Peanut Butter Cookie Dough Due to Expanded Recall by Peanut Corporation of America
    9. Roundtable Calls Presidents Embryonic Stem Cell Decision: Bankrupt
    10. HCPC Calls for Greater Healthcare Savings Through Improved Adherence to Prescription Drug Regimens
    11. GAA Calls on Secretary Clinton to Speak Out Against Gender-Based Violence During Her Africa Trip
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:7/28/2014)... , 28 luglio 2014 ResMed (NYSE: ... di prodotti per la cura dei disturbi respiratori del ... ha avuto un,ingiunzione permanente in Germania contro il produttore ... proibisce la vendita di apparecchiature da indossare in testa, ... e le maschere 220. La sentenza della Corte Regionale ...
    (Date:7/28/2014)... 2014   Cardioxyl Pharmaceuticals, Inc. announced today ... CXL-1427, a novel potential treatment for acute decompensated heart ... company has now initiated dosing of hospitalized patients with ... designed to further evaluate the drug,s safety and tolerability ... Phase I clinical trial evaluated the safety and tolerability ...
    (Date:7/28/2014)... CLARA, Calif. , July 28, 2014  ProteinSimple ... assay for the Simple Western. This new assay allows users ... For the first time, Simple Western users can analyze ... The Simple Western has changed protein analysis as ... hassles of Western blot protocols - no messy gels, ...
    Breaking Medicine Technology:ResMed riceve un'ingiunzione permanente contro APEX in Germania, continua a far valere i propri diritti per i brevetti in Europa 2Cardioxyl Pharmaceuticals Successfully Completes First Clinical Trial For Heart Failure Drug CXL-1427 2ProteinSimple Says "Never Run a Gel Again!" 2
    ... California Cryobank (CCB), the nation,s leading ... branch in Indianapolis, IN.  In conjunction with General ... York, Cambridge, and Palo Alto as California Cryobank,s sixth ... HCLD(ABB), and John Critser, PhD., General BioTech is a ...
    ... with active moderate to severe rheumatoid arthritis (RA) inadequately ... (Humira ® ) and who were actively switched to ... at week 10, and sustained response through week 26 ... from the RESTART study were presented for the first ...
    Cached Medicine Technology:Nation's Leading Sperm Bank Opens Branch in Indianapolis, IN 2New Anti-TNF Study Shows Patients With Rheumatoid Arthritis Receiving REMICADE® After Inadequate Response to Enbrel® or Humira® Demonstrate Marked Clinical Improvement 2New Anti-TNF Study Shows Patients With Rheumatoid Arthritis Receiving REMICADE® After Inadequate Response to Enbrel® or Humira® Demonstrate Marked Clinical Improvement 3New Anti-TNF Study Shows Patients With Rheumatoid Arthritis Receiving REMICADE® After Inadequate Response to Enbrel® or Humira® Demonstrate Marked Clinical Improvement 4New Anti-TNF Study Shows Patients With Rheumatoid Arthritis Receiving REMICADE® After Inadequate Response to Enbrel® or Humira® Demonstrate Marked Clinical Improvement 5New Anti-TNF Study Shows Patients With Rheumatoid Arthritis Receiving REMICADE® After Inadequate Response to Enbrel® or Humira® Demonstrate Marked Clinical Improvement 6New Anti-TNF Study Shows Patients With Rheumatoid Arthritis Receiving REMICADE® After Inadequate Response to Enbrel® or Humira® Demonstrate Marked Clinical Improvement 7
    (Date:7/28/2014)... St. Jude Children’s Research Hospital has ... Defense Employer Support Freedom Award from the Employer Support of ... The award is the highest honor given by the U.S. ... serve in the National Guard and Reserve. , “We deeply ... contributions to the St. Jude mission and to our country,” ...
    (Date:7/28/2014)... 2014...Mothers who live near green spaces deliver babies ... new study, "Green Spaces and Adverse Pregnancy Outcomes" ... Medicine . , A team of researchers from ... Negev (BGU), evaluated nearly 40,000 single live births ... Israel to determine the impact of green surroundings ...
    (Date:7/28/2014)... HIV research findings made possible by a test developed ... Pharmaceutical Sciences (CU School of Pharmacy), AURORA, Colo (July 28, ... in the Colorado Antiviral Pharmacology Laboratory at the CU ... HIV prevention drug called Truvada (a combination of tenofovir/emtricitabine), ... , A study presented during the AIDS 2014 ...
    (Date:7/28/2014)... Modesto, CA (PRWEB) July 28, 2014 At ... an uncomfortable situation where they’re forced to contact the authorities. ... little more difficult than it initially seems. , Not every ... a vehicle get stolen, a person get mugged, or a ... little less obvious, leading onlookers to be more passive than ...
    (Date:7/28/2014)... The report “Industrial Enzymes Market ... Beverages, Cleaning Agents, Bio-Fuel, Animal Feed), & Geography ... and segments the global industrial enzymes market with ... industrial enzymes. It also identifies driving and restraining ... analysis of trends, opportunities, burning issues, winning imperatives, ...
    Breaking Medicine News(10 mins):Health News:St. Jude Children’s Research Hospital Receives Secretary of Defense Employer Support Freedom Award 2Health News:St. Jude Children’s Research Hospital Receives Secretary of Defense Employer Support Freedom Award 3Health News:HIV research findings made possible by a test developed at CU School of Pharmacy 2Health News:Take Action To Protect Your Fellow Citizens 2Health News:Take Action To Protect Your Fellow Citizens 3Health News:Industrial Enzymes Market Worth $5,987.5 Million by 2018 - Report by MarketsandMarkets 2Health News:Industrial Enzymes Market Worth $5,987.5 Million by 2018 - Report by MarketsandMarkets 3Health News:Industrial Enzymes Market Worth $5,987.5 Million by 2018 - Report by MarketsandMarkets 4
    ... of a particular drug than the individual effect of both the ... where the avian bird flu is posing a serious threat across ... is a prescribed drug for seasonal flu, because it will be ... in Asia and reported in other areas mutates into a human ...
    ... have been implicated in a number of human ... pox, measles, rubella, polio, hepatitis, warts, influenza, common ... have now //,reported that a potentially life threatening ... population. ,The findings...indicate the possible presence ...
    ... Carskadon from Bradley Hospital Sleep Laboratory, Brown University has found ... to bed late. Study has found that teens are not ... they get up early in the morning resulting in a ... in the Journal American Academy of Sleep Medicine. ...
    ... US and University of Tokyo, Japan have found a faster ... a bird flu outbreak involving mutant strain of virus occurs. ... the avian virus which may be very lethal and may ... University of Wisconsin-Madison, working with Japanese colleagues from the University ...
    ... more likely to occur in patients who take high ... safety profile of non-steroidal anti-inflammatory drugs (NSAIDs). // Furthermore, ... days after starting an ibuprofen regimen. ... favorable safety profiles of all of the traditional non-selective ...
    ... of India has today assured that there was no real ... // ,The government has set up a nationwide ... the domestic poultry population and migratory birds and to constantly ... as and when required. ,"We are keeping a ...
    Cached Medicine News:Health News:Tamiflu Shortage Can Be Better Handled By Combining It With Probenecid 2Health News:Reports of Hantavirus infection in India raise concerns 2Health News:Faster way of producing Bird flu vaccine using Reverse Genetics 2
    Triad Plus PVP-I Scrub Winged Sponges...
    Prevail is a fast-acting, effective antimicrobial gel that makes preoperative preps easier. This unique gel formulation comes in a specifically designed, easy to use applicator for excellent flow con...
    The applicator is designed for a smooth delivery of the solution for surgical procedures....
    ... Performance Panel consists of plasma specimens with ... for antibodies to the Hepatitis C Virus. ... manufacturers and diagnostic laboratories to evaluate their ... test systems are included for comparative analysis ...
    Medicine Products: