Navigation Links
IDSA Proposes New Pathway For Antibiotic Approval
Date:3/8/2012

WASHINGTON, March 8, 2012 /PRNewswire-USNewswire/ -- Congress will consider a new drug approval pathway to encourage development of critically needed, lifesaving antibiotics as part of a strategy to address the public health crisis of antibiotic resistance. The Infectious Diseases Society of America (IDSA) proposed the new pathway, the "Special Population Limited Medical Use (SPLMU)" mechanism, to provide an important new approval option for companies interested in developing drugs to treat patients with serious infections where few or no treatment options exist.

IDSA submitted the proposal to the House Energy and Commerce Committee Subcommittee on Health today during a hearing on the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) reauthorization legislation. During the hearing, lawmakers will consider whether to incorporate within PDUFA pending legislation known as the Generating Antibiotic Incentives Now (GAIN) Act, which proposes incentives to address the dry antibiotic research and development (R&D) pipeline. PDUFA is considered one of the few must-pass bills this year in Congress.

"Antimicrobial resistance is unequivocally one of the world's greatest public health threats, and we've been sounding the alarm about it – and the lack of new antibiotics in development – for years," said Brad Spellberg, MD, co-chair of IDSA's Antimicrobial Availability Task Force. "This new mechanism provides the opportunity to address this public health crisis while there is still time to fix it."

The SPLMU mechanism streamlines the approval pathway and enab
'/>"/>

SOURCE Infectious Diseases Society of America (IDSA)
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. FDA Proposes Lower Risk Classification, Special Controls for External Pacemakers
2. FDA Proposes Guidelines That Clarify Benefit-Risk Determinations for Medical Devices
3. FDA Proposes New Policy for Some Diagnostic and Radiology Devices
4. Valeant Pharmaceuticals Proposes to Acquire Cephalon, Inc. for $73 Per Share in Cash
5. Mangrove Partners Proposes Fully-Financed Dividend Recapitalization to Board of CPEX Pharmaceuticals, Inc.
6. FDA Proposes Withdrawal of Low Blood Pressure Drug
7. American Association for Homecare Proposes Strong Anti-Fraud Measures in Medicare, Applauds HHS Testimony Today That Pledges to "Stop Fraud Before it Starts"
8. ActivBiotics Proposes Development Strategy for Its Novel Rifamycin Antibiotics
9. Cancer Cure Coalition Proposes Major Changes at the FDA
10. New Gene Study of ADHD Points to Defects in Brain Signaling Pathways
11. Functional Brain Pathways Disrupted in Children with ADHD
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2014)... , Aug. 27, 2014  Hill-Rom Holdings, Inc. ... to a management presentation at the Morgan Stanley Global ... EDT. You are invited to listen to ... http://ir.hill-rom.com/events.cfm or access it directly at http://cc.talkpoint.com/morg007/090814a_ac/?entity=26_7CLOGQP ... available one hour after conclusion of the live event ...
(Date:8/27/2014)... 2014 Sihuan Pharmaceutical Holdings Group Ltd. ... leading pharmaceutical company with the largest cardio-cerebral vascular ... prescription drug market, today announced the unaudited ... (collectively the "Group") for the six months ended ... HighlightsFor the Six months ended 30 JuneKey Income ...
(Date:8/27/2014)... , Aug. 27, 2014  CVS Caremark (NYSE: ... into a new clinical affiliation with MedStar Health, a ... Maryland and the Washington, ... high-quality, affordable health care services for patients. Through this ... access to clinical support, medication counseling, chronic disease monitoring ...
Breaking Medicine Technology:Sihuan Pharmaceutical Announces 2014 Interim Results 2Sihuan Pharmaceutical Announces 2014 Interim Results 3Sihuan Pharmaceutical Announces 2014 Interim Results 4Sihuan Pharmaceutical Announces 2014 Interim Results 5Sihuan Pharmaceutical Announces 2014 Interim Results 6Sihuan Pharmaceutical Announces 2014 Interim Results 7CVS Caremark Announces New Clinical Affiliation with MedStar Health 2CVS Caremark Announces New Clinical Affiliation with MedStar Health 3
... 2010 Curemark LLC , a drug research and ... today that it has been awarded a grant by the ... Program to advance the development of its lead product CM-AT ... at 18 sites around the US. The QTDP ...
... VALLEY, Calif., Nov. 2, 2010 Spectros Corporation ... with the T-Stat VLS Tissue Oximeter at the ... newly released data was presented during poster sessions ... Circulation: Pharmacology/Physiology", held at the American Society of ...
Cached Medicine Technology:Curemark Awarded Qualifying Therapeutic Discovery Project (QTDP) Grant 2Spectros Presents New Clinical Studies Using T-Stat VLS Tissue Oximeter at Anesthesiology 2010 2
(Date:8/27/2014)... August 28, 2014 Recently, iFitDress.com, a ... announced its new designs of romantic bridal gowns ... enjoy a promotional price (up to 66 percent off) ... the company’s product line has been updated with these ... and patient. iFitDress.com hopes that all clients can gain ...
(Date:8/27/2014)... Calif. (PRWEB) August 27, 2014 Seventy-three ... of Pharmacy (SoP) celebrated the beginning of their careers ... on Saturday, August 23. Students entering a four-year PharmD ... and care ?to welcome them into the profession as ... the ceremony held at the Garrison Theater in Claremont, ...
(Date:8/27/2014)... 2014 Ticket Down is a ... at Levi’s Stadium in Santa Clara. Levi’s Stadium is ... just opened in July and will host their first international ... Chile. These are two of the best teams that are ... and will look to continue their successes from the tournament ...
(Date:8/27/2014)... Dr. Stewart Shofner and ... of patients suffering from impaired vision. Some of the ... correction surgery . Recently, Dr. Shofner has noticed a ... eye exam and also online. To help patients understand ... about glaucoma. , 1)    Myth: People with perfect vision won’t ...
(Date:8/27/2014)... New York (PRWEB) August 27, 2014 ... our society today, big business has taken notice. With ... form of medical cannabis friendly legislation on their books ... While states such as New York and Florida are ... their medical marijuana laws a void of reliable information ...
Breaking Medicine News(10 mins):Health News:Promotion For Romantic Bridal Gowns Launched By Professional Company iFitDress.com 2Health News:Founding Class of the KGI School of Pharmacy Formally Welcomed into the Profession at a Traditional White Coat Ceremony 2Health News:Mexico vs. Chile Tickets at Levi’s Stadium: Ticket Down Cuts Ticket Prices for Inaugural Soccer Match between Chile and Mexico in Santa Clara 2Health News:Mexico vs. Chile Tickets at Levi’s Stadium: Ticket Down Cuts Ticket Prices for Inaugural Soccer Match between Chile and Mexico in Santa Clara 3Health News:Renowned Eye Surgeon Dr. Stewart Shofner Debunks Top Five Myths About Glaucoma 2Health News:Renowned Eye Surgeon Dr. Stewart Shofner Debunks Top Five Myths About Glaucoma 3Health News:Renowned Eye Surgeon Dr. Stewart Shofner Debunks Top Five Myths About Glaucoma 4Health News:The Marijuana Real Estate Market Opens Up 2Health News:The Marijuana Real Estate Market Opens Up 3
... release is available in Spanish . , ... that, for the first time since the report was first ... cancers combined are decreasing for both men and women, driven ... of cancer. The report notes that, although the decreases ...
... Chantel ,Chani, Christie, teen,pop star, and daughter of NBA power couple ... Foundation on December 1, 2008 which is World AIDS,Day. To kick ... bestselling,book, ,I Want To Live: A Teenager,s Guide To Finding Self ... education and awareness. , "It ...
... women lagging behind men, study finds , , TUESDAY, Nov. 25 ... system that gives preference to patients with the greatest need, ... among those waiting for new livers are narrowing. , Blacks ... too sick for a transplant while on the waiting list, ...
... (Bayer) has agreed to pay the United States$97.5 million ... to a number of diabetic suppliers and caused those ... Department announced today. The settlement resolves allegations that ... company paid 11 diabetic suppliers to convert their patients ...
... spent at least 14 hours a week taking care ... is the unexpected finding of a University of Michigan ... of the Association for Psychological Science. , The study ... and longevity, it really is better to give than ...
... across race, education levels, and could affect quality of ... News) -- How well a person on Medicare understands ... a new study says. , The report, published ... , found that a third of the surveyed Medicare ...
Cached Medicine News:Health News:Annual report to the nation finds declines in cancer incidence and death rates 2Health News:Annual report to the nation finds declines in cancer incidence and death rates 3Health News:Annual report to the nation finds declines in cancer incidence and death rates 4Health News:Annual report to the nation finds declines in cancer incidence and death rates 5Health News:Teen Pop Star, Chantel 'Chani' Christie, Launches the Chani Girl Foundation to Bring Education/Awareness on HIV/AIDS 2Health News:New System Improves Distribution of Donated Livers 2Health News:New System Improves Distribution of Donated Livers 3Health News:Bayer Healthcare to Pay U.S. $97.5 Million to Settle Allegations of Paying Kickbacks to Diabetic Suppliers 2Health News:In sickness and health: Caring for ailing spouse may prolong your life 2
... a service that directly connects the ... customers laboratory to the Thermo Electron ... and Runcorn, U.K.* By using a ... site, high-value support services are made ...
The Shandon Citadel is a low cost, reliable, time-tested carousel-type tissue processor with convenient touch key operation. The Citadel 2000 has 110 cassette capacity and the Citadel 1000 has a cap...
... Grosslab Senior Grossing Wokrstation is a ... designed for gross examination and sectioning ... construction, 3 efficient ventilation systems and ... for water faucets, table rinses, disposals ...
The HypercleanTM 1 is a versatile, durable fume handling station. The Hyperclean 1 fume handling station unit comes complete with one (1) blower unit and one (1) charcoal filter....
Medicine Products: