Navigation Links
FDA Details Access to 'Investigational' Drugs
Date:8/12/2009

tigational drugs are ones that are in the process of being approved by the FDA for use but are still being tested for safety and effectiveness. "We don't know as much about these drugs as we do approved drugs," Woodcock said.

The new rules will not interfere with the drug-approval process, officials said.

"We want to achieve a balance between the need to gather information to demonstrate whether drugs work and the fact that critically ill patients urgently want access and may be willing to take greater risks if they have no reasonable alternatives," said FDA Commissioner Dr. Margaret A. Hamburg. "The expanded access procedures will allow patients to get access without disrupting the gathering of information."

Under the new protocol, single patients as well as intermediate- and large-sized groups could gain access to experimental drugs.

The second rule published Wednesday details the circumstances under which manufacturers can actually charge patients for use of investigational drugs.

"Making these drugs available outside of a clinical trial can be costly to manufacturers," Woodcock said. "By permitting charging for expanded access we hope to stimulate more companies to provide investigational drugs."

According to Woodcock, deciding which companies will be allowed to recover part of their costs this way will be a "judgment call" on the part of the FDA. "They will have to give us financial information and they will have to convince us that the drug would not be developed absent this charging," she said. The company could also charge for administrative costs and for the cost of monitoring the patient, she added.

It's possible that some patients could get access to investigational drugs as early as late-stage Phase I trials, the earliest types of trials, Woodcock said.

"Together, the two final rules announced will make wider availability of investigational drugs possible by providing c
'/>"/>

Copyright©2009 ScoutNews,LLC.
All rights reserved

1

GOOD

Page: 1 2 3

Related medicine news :

1. Study details regulation of vital tumor suppressor gene p53
2. University of Texas Study Details Lengthy Payment Delays for Medicare Part D Prescription Drug Claims, Confirming Need for Legislative Fix
3. New Case Study Details How an Illinois Hospital Created a Safe Lifting Team that Dramatically Reduced Injuries, Increased Staff Satisfaction
4. Morris Animal Foundation 2008 Sponsorship Guide Available, Details Current Animal Health Studies
5. New RAPS White Paper Details Career Development of Healthcare Products Regulatory Professionals
6. Details of Oregon Wine Regions First Luxury Inn, Spa Revealed at Groundbreaking Ceremony
7. Young Innovations, Inc. Provides Third Quarter Conference Call Details
8. Rural/Metro Enters Into Amendment and Waiver to Its Senior Credit Facility; Provides Restatement Details
9. Free White Paper Details Hospital Strategies for Meeting Joint Commission Compliance Requirements in the Environment of Care
10. Marketing and Meeting Details (M2D) Officially Launches an Innovative Life Sciences Marketing and Communications Company
11. White Paper Details How to Choose the Right EMS Provider for Medical Products Outsourcing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/16/2009)... For wounded U.S. servicemen and women recovering ... the holidays can be a particularly difficult time. ... more than ever on the healing power of connecting ... just got easier for Walter Reed patients as Verizon ... provide hundreds of minutes of holiday talk time for ...
(Date:12/16/2009)... result of C3: Colorectal Cancer Coalition,s advocacy efforts, $15 ... is included in the final Fiscal Year 2010 Defense ... will research cancers, like colorectal cancer, that are not ... research programs run by the U.S. Army Medical Research ... in funding for this new cancer research program was ...
(Date:12/16/2009)... is long-term goal, researchers say , , WEDNESDAY, Dec. ... to predict whether a patient will suffer a second ... "This is an important new tool because studies have ... after a first stroke are more likely to die ... General Hospital and Harvard Medical School, said in an ...
(Date:12/16/2009)... Study suggests it plays a role in reducing inflammation ... -- A gene variant that plays a role in ... asthma as well as adults who smoke. , Researchers ... the MMP12 gene had a lower risk of developing ... brought on by smoking. , "The gene seems to ...
(Date:12/16/2009)... an advance that could help ease health and environmental ... development of technology for changing the behavior of nanoparticles ... into the environment. Their study was published in ACS, ... Jarvie from the UK Centre for Ecology and Hydrology ... the production of nanoparticles particles less than 1/1000th ...
Breaking Medicine News(10 mins):Health News:Verizon Wireless Donates $10,000 in Long-Distance Calling Cards to Soldiers at Walter Reed Hospital 2Health News:House Creates New Cancer Research Program 2Health News:House Creates New Cancer Research Program 3Health News:New Stroke Tool May Predict Early Recurrence 2Health News:Gene Variant Seems to Guard Against Asthma, COPD 2Health News:Gene Variant Seems to Guard Against Asthma, COPD 3Health News:Behavior modification could ease concerns about nanoparticles 2
... be spurring unrealistic expectations, study suggests , , WEDNESDAY, Nov. ... are far likelier than those in the 1970s to ... research shows. , They,re also much more likely to ... even though other research shows that today,s students do ...
... 12 Covenant House International is,releasing its First Annual Report ... outlook for their future. America,s kids in crisis will be,the ... on,Thursday, November, 20, 5:30 pm, in Times Square., "Over ... on our,streets every year. We were able to help 70,387 ...
... Indicates that a Patient,s or Loved One,s Hearing Loss Can ... to Inefficiency and Even Medical ... among those,who require the assistance of a caregiver is causing ... according to a new survey,released by Songbird Hearing, Inc. ( ...
... 12 Hyperion,Therapeutics, Inc. today reported completion ... trial designed to evaluate the safety, tolerability ... (sodium phenylbutyrate),the current standard of care in ... trial will be presented at an upcoming ...
... Spin-Off and Listing ... on NYSE ... Be Listed on NASDAQ, HONG KONG, Nov. 12 /Xinhua-PRNewswire-FirstCall/ -- China,s leading,integrated ... Group", HKEx: 8180) today,announced the interim results of financial year 2008/09. During the ...
... 12 The Quantum Group,Inc. (Amex: QGP ... organization, in anticipation of a scheduled presentation to ... & CEO Noel J. Guillama later this morning, ... base to over 3,650 using the community,health systems ...
Other Medicine News:Health News:U.S. Teens Brimming With Self-Esteem 2Health News:U.S. Teens Brimming With Self-Esteem 3Health News:U.S. Teens Brimming With Self-Esteem 4Health News:Plight of Homeless Youth Will be Focus of Nov. 20 Times Square Vigil 2Health News:Plight of Homeless Youth Will be Focus of Nov. 20 Times Square Vigil 3Health News:Hearing Loss Presents a Significant Challenge for Rising Number of Caregivers 2Health News:Hearing Loss Presents a Significant Challenge for Rising Number of Caregivers 3Health News:Hearing Loss Presents a Significant Challenge for Rising Number of Caregivers 4Health News:Hyperion Therapeutics Completes Phase 2 Data Analysis and Schedules End of Phase 2 Meeting With FDA for HPN-100 in the Chronic Treatment of Urea Cycle Disorders 2Health News:Hyperion Therapeutics Completes Phase 2 Data Analysis and Schedules End of Phase 2 Meeting With FDA for HPN-100 in the Chronic Treatment of Urea Cycle Disorders 3Health News:Golden Meditech Releases FY2008/09 Interim Results 2Health News:Golden Meditech Releases FY2008/09 Interim Results 3Health News:The Quantum Group Announces Continued Growth of Patient Base and Preliminary Revenue Guidance 2Health News:The Quantum Group Announces Continued Growth of Patient Base and Preliminary Revenue Guidance 3Health News:The Quantum Group Announces Continued Growth of Patient Base and Preliminary Revenue Guidance 4
(Date:12/16/2009)... 16 Wound Management Technologies, Inc. ... provider of specialty medical products, announced today ... moving toward productization of its patented orthopedic ... anticipates products to be introduced in Q3 ... be a multi-billion dollar international market. ,, ...
(Date:12/16/2009)... CHICAGO, Dec. 16 A ... to manage the clinical review of specialty pharmaceuticals ... number of drugs reviewed while reducing costs. ,, ... technology company with health plan clients representing over ... WellPoint, Inc. (NYSE: WLP ), adapted ...
(Date:12/16/2009)... AVAX Technologies, Inc. (Pink Sheets: AVXT) ("AVAX" or ... a bridge loan financing (the "2009 Financing") pursuant ... (the "Agreement") with Firebird Global Master Fund, Ltd., ... a convertible promissory note, due June 30, 2010, ... issued a warrant to purchase an aggregate of ...
Breaking Medicine Technology:Wound Management Technologies, Inc. Targets Multi-Billion Dollar Biomaterials Market; Releases Update on Resorbable Orthopedics 2Wound Management Technologies, Inc. Targets Multi-Billion Dollar Biomaterials Market; Releases Update on Resorbable Orthopedics 3American Imaging Management's New Specialty Drug Program Delivers Immediate Results 2American Imaging Management's New Specialty Drug Program Delivers Immediate Results 3American Imaging Management's New Specialty Drug Program Delivers Immediate Results 4AVAX Technologies, Inc. Closes Bridge Financing 2AVAX Technologies, Inc. Closes Bridge Financing 3AVAX Technologies, Inc. Closes Bridge Financing 4New Leadership Team at International Trachoma Initiative to Build Stronger Partnerships to Eliminate Blinding Trachoma 12872 1New Leadership Team at International Trachoma Initiative to Build Stronger Partnerships to Eliminate Blinding Trachoma 12872 2Sharing Miracles Television Program to Feature Legendary Rapper and Popular Actor Ice T 50540 1Sharing Miracles Television Program to Feature Legendary Rapper and Popular Actor Ice T 50540 2Sharing Miracles Television Program to Feature Legendary Rapper and Popular Actor Ice T 50540 3Sharing Miracles Television Program to Feature Legendary Rapper and Popular Actor Ice T 50540 4Sharing Miracles Television Program to Feature Legendary Rapper and Popular Actor Ice T 50540 5Sharing Miracles Television Program to Feature Legendary Rapper and Popular Actor Ice T 50540 6Sharing Miracles Television Program to Feature Legendary Rapper and Popular Actor Ice T 50540 7Sharing Miracles Television Program to Feature Legendary Rapper and Popular Actor Ice T 50540 8SIRIUS XMs Doctor Radio to Air July 4th Family Special 24 Hours About Our Kids 3A Why Kids Behave the Way They Do 50535 1SIRIUS XMs Doctor Radio to Air July 4th Family Special 24 Hours About Our Kids 3A Why Kids Behave the Way They Do 50535 2SIRIUS XMs Doctor Radio to Air July 4th Family Special 24 Hours About Our Kids 3A Why Kids Behave the Way They Do 50535 3SIRIUS XMs Doctor Radio to Air July 4th Family Special 24 Hours About Our Kids 3A Why Kids Behave the Way They Do 50535 4SIRIUS XMs Doctor Radio to Air July 4th Family Special 24 Hours About Our Kids 3A Why Kids Behave the Way They Do 50535 5SIRIUS XMs Doctor Radio to Air July 4th Family Special 24 Hours About Our Kids 3A Why Kids Behave the Way They Do 50535 6
... Schering-Plough,Corporation (NYSE: SGP ) announced today ... from about 60 clinical studies relating,to its growing ... 44th,Annual Meeting of the American Society of Clinical ... Data will be presented on TEMODAR(R),(temozolomide) Capsules, CAELYX(R) ...
... Post-hoc analysis of pivotal studies presented at the National Lipid ... Association,s Annual Scientific Sessions, ... data from post-hoc analyses of three pivotal studies,demonstrated that the ... lower A1C in patients with type 2 diabetes,mellitus by 1% ...
Other Medicine Technology:About 60 Clinical Studies Regarding Schering-Plough's Oncology Compounds Will be Presented at ASCO 2Welchol(TM) Lowered A1C by a Mean 1 Percent or Greater When Added to Metformin-, Insulin-, or Sulfonylurea-Based Therapy in 47 Percent of Patients Evaluated 2Welchol(TM) Lowered A1C by a Mean 1 Percent or Greater When Added to Metformin-, Insulin-, or Sulfonylurea-Based Therapy in 47 Percent of Patients Evaluated 3Welchol(TM) Lowered A1C by a Mean 1 Percent or Greater When Added to Metformin-, Insulin-, or Sulfonylurea-Based Therapy in 47 Percent of Patients Evaluated 4Welchol(TM) Lowered A1C by a Mean 1 Percent or Greater When Added to Metformin-, Insulin-, or Sulfonylurea-Based Therapy in 47 Percent of Patients Evaluated 5Welchol(TM) Lowered A1C by a Mean 1 Percent or Greater When Added to Metformin-, Insulin-, or Sulfonylurea-Based Therapy in 47 Percent of Patients Evaluated 6
Freedom Cath® is a latex, self-adhering, one-piece catheter designed for everyday wear....
The Freedom Clear catheter is a 100% latex-free, self-adhering, one piece catheter with an ultra-thin sheath for every day wear....
The Freedom Clear® LS Long Seal is a 100% latex-free, self-adhering, one piece catheter with an ultra-thin sheath for everyday wear. Its long seal provides added security....
Freedom Clear® SS Sport Sheath is a 100% latex-free, self-adhering, one piece catheter with an ultra-thin sheath designed for everyday wear. Its brief sheath minimizes roll at the base of the p...
Medicine Products: