Navigation Links
Medical Community Reacts to Obama and Congressional Plans to Approve Generic Forms of Biologic Medicines
Date:4/16/2009

National Press Club Event to Highlight Patient Safety and Discuss Policy Recommendations for Moving Forward

WASHINGTON, April 16 /PRNewswire-USNewswire/ -- The Obama administration's goal of expanding the availability of generic forms of biologic drugs - and a variety of congressional efforts to fulfill the administration's goal - will be discussed on April 21st at the National Press Club in Washington, DC when the Jefferson School of Population Health hosts a forum on the quality and safety issues surrounding the creation of a regulatory pathway for follow-on biologic drugs. Attendees will also offer recommendations and key take-away messages for policy makers on Capitol Hill and in the administration.

The outcome of this debate is likely to have far-reaching implications with regard to access, cost, safety, and therapeutic impact for thousands of patients with serious, life-threatening, and chronic diseases. For this reason, it is critical that decision makers hear from all key stakeholders who have information and insights on the various touch points of this important health care issue before reaching a conclusion.

Many important factors must be taken into consideration when developing an appropriate process to review, assess, approve, and regulate the use of follow-on biologics and other related complex molecules:

  • How to protect patient safety;
  • What level of evidence should be required for consideration of use of a follow-on product;
  • What factors should be considered when creating guidelines around interchangeability;
  • How will post-marketing surveillance be conducted for these new products to monitor for adverse events;
  • How will we determine efficacy; and
  • What are the ethical considerations when conducting a cost-benefit analysis?

<
'/>"/>
SOURCE Jefferson School of Population Health
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Several Minnesota Medical Groups Improve Care for Patients Served by Minnesota Health Care Programs, but Disparities Gap Remains
2. Medical International Technology Inc. "MIT" announces a minimum of 6 million dollars exclusive agreement for a period of 5 years with a Malaysian Distributor for its Med-Jet(R) Needle-Free Jet-Injector
3. Varian Medical Systems to Exhibit the Latest X-Ray Image Detectors, and X-Ray Tubes at the CMEF Show in Shenzhen, China
4. California Certifying Board for Medical Assistants Signs Exclusive Contract with Pearson VUE
5. ATS Medical Announces Regulatory Approval of the ATS Open Pivot AP360 Mechanical Heart Valve in Japan
6. MedicAlert Brings History of Saving Lives to Chicago for Inaugural Thrive Allergy & Gluten-free Expo
7. Chicagos Top Minds Join National Business and Health Leaders in Addressing Medical Innovation, Highlighting Policies Needed to Maintain U.S. Competitiveness in Medical Science and Discovery
8. Medical Mutual of Ohio Names Dugan Chief Legal Counsel
9. Frost & Sullivan Recognizes Zecotek Photonics Medical Imaging Achievement, Development of Next-Generation Scintillation Crystals and Photo Detector Technology
10. Bruce R. Korf, MD, PhD is Named President of the American College of Medical Genetics
11. Delta Employees Blanket Salt Lake City Medical Center With Warm Gifts
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... Thompson HealthDay Reporter THURSDAY, ... wars that break out regularly between outspoken celebrities or loudmouth ... own relationship, a new study suggests. High amounts of ... if the couple is in a long-term relationship, according to ... In turn, that friction can lead to cheating and breakups, ...
(Date:7/10/2014)... responders felt better prepared to respond to an active ... a new study in the journal Prehospital and ... specifically examine the EMS provider comfort level with respect ... yet been neutralized or working with law enforcement personnel ... High School shooting, the Virginia Tech campus shooting, the ...
(Date:7/10/2014)... amount of alcoholic beverages consumed, even for light-to-moderate ... risk of coronary heart disease, lower body mass ... new multi-center study published in The BMJ ... Medicine at the University of Pennsylvania. The latest ... that consuming light-to-moderate amounts of alcohol (0.6-0.8 fluid ...
(Date:7/10/2014)... The U.S. Department of Health and Human Services ... (UH) Case Medical Center Seidman Cancer Center totaling $4.7 ... improving care for patients with complex cancer. , ... unique model developed at UH to enhance care for ... demonstrated need for high health care utilization. ...
(Date:7/10/2014)... imaging far outweigh the risks when children receive The ... Radiation Dose. However, overuse and misuse of imaging change ... collaborative effort to ensure a national protocol is put ... Journal of Patient Safety , calls for the American ... Commission, and the Centers for Medicare & Medicaid Services ...
Breaking Medicine News(10 mins):Health News:Are You Tweeting Your Marriage Away? 2Health News:Are You Tweeting Your Marriage Away? 3Health News:Active shooter training increases comfort level of emergency responders 2Health News:New study shows drinking alcohol provides no heart health benefit 2Health News:UH Case Medical Center awarded $4.7 million grant from HHS 2Health News:UH Case Medical Center awarded $4.7 million grant from HHS 3Health News:Mayo Clinic calls for standardization of safe imaging protocols for children 2
... Analysis of a drug regimen approved by the F.D.A. ... (bevacizumab added to the standard chemotherapy regimen carboplatin and paclitaxel) ... received this regimen did not have improved survival compared to ... alone, according to a study in the April 18 issue ...
... The Prospective Surveillance Model, an innovative new model of breast ... American Cancer Society,s journal, Cancer released on April ... by women with breast cancer and offers hope for an ... through rehabilitation and exercise. APTA members Nicole ...
... (Toronto) People with an opioid addiction had the highest risk ... drugs, according to a new study by the Centre for ... on opioids, the risk of death was 5.71 times higher ... gender and race. Those with methamphetamine use disorders were next ...
... plays an integral role in physical health dates back to ... referred to as the founder of medicine, wrote "natural ... University of Missouri team has tapped into the science and ... award-winning program. Called "Taking Care of You: Body-Mind-Spirit," ...
... undergoing chemoradiation therapy (CRT) for head and neck cancer, ... short-term improvement in swallowing function; however, there were no ... and controls at nine or 12 months following treatment, ... Archives of Otolaryngology Head & Neck Surgery ...
... MONDAY, April 16 (HealthDay News) -- Tattoos and body piercings ... in western societies, but a new study in France found ... than their peers. In the study, researchers asked ... they left bars and other drinking establishments. The readings showed ...
Cached Medicine News:Health News:Study examines drug regimen for the treatment of non-small cell lung cancer among older patients 2Health News:Study examines drug regimen for the treatment of non-small cell lung cancer among older patients 3Health News:Model for breast cancer rehab featured in supplement to ACS journal, Cancer 2Health News:Opioids associated with highest risk of death 2Health News:MU receives national award for using mind-body approach to improve health 2Health News:Swallowing exercises linked with short-term improvement among patients with head and neck cancer 2Health News:Tattoos, Piercings Tied to Heavier Drinking in French Study 2
(Date:7/10/2014)...  Breg, Inc., a premier provider of sports ... knee brace with new innovations to help people, ... to active lifestyles.  FreeRunner,s patent-pending design acts on ... when patients need it most, and the ability ... Patellofemoral issues are the most common cause of ...
(Date:7/10/2014)... 10, 2014  RESMED INC. (NYSE: RMD ) ... fiscal year ended June 30, 2014 results on Thursday, July ... A press release with ResMed,s results will be issued after ... a webcast to discuss operating results and future outlook. ... p.m. US Pacific Time and the live webcast of the ...
(Date:7/10/2014)... , July 10, 2014  BC Technical, the largest ... MiE America , Inc., a leading provider of Siemens ... a long-term agreement naming BC Technical as the authorized ... MiE and BC Technical announced today that ... establish BC Technical as the service and systems provider ...
Breaking Medicine Technology:Breg Introduces Knee Brace to Help Runners with Patellofemoral Pain Syndrome 2ResMed To Announce Fourth Quarter And Fiscal Year-End 2014 Results 2BC Technical Partners With MiE America To Be Authorized Provider Of Systems & Service 2
... SAN DIEGO, June 8, 2011 Amylin Pharmaceuticals, Inc. (NASDAQ: ... the following statement regarding the decision of the United States ... its motion for a preliminary injunction to enjoin Eli Lilly ... in anticompetitive activity and breaching its diabetes collaboration agreement with ...
... CAMBRIDGE, Mass., June 8, 2011 Regulus Therapeutics ... development of innovative medicines targeting microRNAs, and Alnylam Pharmaceuticals, ... therapeutics company, today announced the publication in ... about the antagonism of microRNA-103 and microRNA-107 (miR-103/107). Data ...
Cached Medicine Technology:Amylin Pharmaceuticals Issues Statement Regarding U.S. District Court Order 2Amylin Pharmaceuticals Issues Statement Regarding U.S. District Court Order 3Amylin Pharmaceuticals Issues Statement Regarding U.S. District Court Order 4Nature Article Implicates microRNAs in the Pathogenesis of Obesity and Type 2 Diabetes 2Nature Article Implicates microRNAs in the Pathogenesis of Obesity and Type 2 Diabetes 3Nature Article Implicates microRNAs in the Pathogenesis of Obesity and Type 2 Diabetes 4Nature Article Implicates microRNAs in the Pathogenesis of Obesity and Type 2 Diabetes 5Nature Article Implicates microRNAs in the Pathogenesis of Obesity and Type 2 Diabetes 6Nature Article Implicates microRNAs in the Pathogenesis of Obesity and Type 2 Diabetes 7
Optimized 180W Xenon lamp, low fan noise with reduced air turbulence, compact housing. Built for monitor applications and all endoscope dimensions. Ideal for video recording applications....
High-intensity 300-watt xenon lamp, with continuously adjustable output from 0 to 100% manually or automatically by camera video output signal....
Integrated electronics, single-chip CCD camera with PAL and NTSC output. PAL output at 460 lines, NTSC output at 470 lines. 30mm focal length. 90mm length x 20mm diameter....
Integrated electronics, single-chip CCD camera with PAL and NTSC output. PAL output at 625 lines, NTSC output at 525 lines. 23mm focal length. Output via Y/C mini-DIN-4 port. 135mm length x 44mm ...
Medicine Products: