Navigation Links
FDA Struggles to Keep Pace With Requests for Generics
Date:10/4/2007

ts, for which there are no patent problems or exclusivity protections when they are submitted for approval, will receive expedited review, officials said.

There are some 215 full-time FDA staffers working on reviews of generic drug applications. Under the GIVE program, the agency hopes to hire and train new generic drug reviewers, provided funding is approved by Congress. The agency also plans to enhance its use of computer programs for handling drug submissions, officials said.

All generic drugs undergo a scientific review for quality, safety, and effectiveness. And drug manufacturers must prove that a generic drug has the same dosage, strength, route of administration, and intended use as an approved brand-name drug, the FDA said.

Drug makers also must show that a generic drug has the same amount of active ingredient as a brand-name drug and delivers it in the same amount of time. This "bioequivalence" ensures that a generic drug has the same therapeutic benefit as a brand-name drug.

Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association, doesn't think the FDA's efforts have been enough.

"While we all share the goal of increasing efficiency in the generic approval system, another initiative in name only simply will not get the job done," Jaeger said in a prepared statement. "What consumers need is for the FDA to address the core fundamental issues that are blocking timely consumer access to affordable generics."

These issues include the citizen petition process, scientific consultations, enhanced communication, more inspection resources, accountability and structure of the Office of Generic Drug Program, she said.

"For years, the agency has tinkered around the edges with programs and initiatives designed to increase efficiency but have proven to yield little in the way of significant results," Jaeger said.

To help solve these problems, the association is sugges
'/>"/>

Copyright©2007 ScoutNews,LLC.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Malaysia Struggles to Control Hand, Foot-and-Mouth Disease In Sarawak
2. "Sleep training" effective against bedtime struggles
3. Indonesia Struggles Against Bird Flu and the Drug Industry as Well
4. Ukraine Struggles Against Fake Drug Trade
5. Uttar Pradesh Struggles to Contain Japanese Encephalitis
6. Canadian Street Prostitutes Requests Protection
7. New Zealand Requests Details from Britain about ‘Black Sheep
8. Patients Requests for Antidepressants can Influence Physician Evaluation of Depression
9. Cyberkinetics Requests FDA to Sell Nerve Growth Stimulation System
10. FDA Requests Label Change for All Sleep Disorder Drug Products
11. FDA Requests Recall of All Shelhigh Medical Devices
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2014)... Dennis Thompson HealthDay Reporter ... of developing celiac disease isn,t reduced by breast-feeding. Nor will ... gluten to an infant,s diet help prevent celiac disease. ... studies in the Oct. 2 New England Journal of ... that a child could avoid celiac disease if mothers breast-feed ...
(Date:10/1/2014)... researchers from the University of Adelaide have developed a ... of a good outcome from treatment - from their ... on a range of factors, including clinical symptoms, cognitive ... in the patient,s blood. , Speaking in the lead ... University,s Head of Psychiatry , Professor Bernhard ...
(Date:10/1/2014)... research co-funded by the Engineering and Physical Sciences ... of the UK,s vital industrial control systems which ... electricity grid, and the rail network. , ... from hackers or malware infiltrating the systems behind ... Institute in Trustworthy Industrial Control Systems (RITICS), based ...
(Date:10/1/2014)... Marriagelifeinsurance.com has released a new blog ... couples. , Senior citizens can purchase a joint ... loved ones. A joint policy is cheaper, but will ... , Life insurance can be used to cover ... be purchased online, as the application process is simple ...
(Date:10/1/2014)... 01, 2014 Phoseon Technology, the pioneer ... to expand the business worldwide. This rapid growth includes ... capacity for manufacturing efforts. The company has experienced average ... years and expects this growth to continue in the ... gains worldwide adoption. , “We are very pleased ...
Breaking Medicine News(10 mins):Health News:Infant's Early Diet Doesn't Change Celiac Disease Risk, Study Finds 2Health News:Infant's Early Diet Doesn't Change Celiac Disease Risk, Study Finds 3Health News:Predicting the future course of psychotic illness 2Health News:£2.5 million to recognize and reduce cyber-attack threats to critical infrastructure 2Health News:Elderly Life Insurance - Find Life Insurance for Retired Couples! 2Health News:Phoseon Technology Continues to Drive Growth Worldwide 2
... , , TAMPA, Fla. ... Solutions, today announced the appointment of Michael Unhjem as a member of ... (Logo: http://www.newscom.com/cgi-bin/prnh/20090709/FL43703LOGO ) , ... of Blue Cross Blue Shield (BCBS) of North Dakota, was unanimously elected ...
... SEATTLE, July 20 Group Health Cooperative medical centers received ... the Puget Sound Health Alliance Community Checkup . Group ... nine medical groups in the Puget Sound region that were rated on ... regional average" scores. , , "We support ...
... , MINNEAPOLIS, July 20 ... into a business relationship with Cardiocom(R) to provide advanced home ... Experts in Telehealth(SM), is a world class developer, manufacturer and ... , Cardiocom,s telehealth system provides an interactive ...
... 20 N y comed tod a y announced t h e su b mission of a N e ... n d Drug Administr a tion ( F DA) for ... oral treatme n t for patie n t s ... i ssion is ba s e d on enc ou raging result s fro m ...
... , , ... DIEGO, July 20 Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX ) today ... its investigational drug for the treatment of obesity, met their co-primary endpoints. ... O besity R esearch, or COR, program of more ...
... , , ... -- Allscripts (Nasdaq: MDRX ) announced today ... Human Resources. Ms. Adams brings to the position more than 20 ... high tech industry, most recently as Vice President of Human Resources ...
Cached Medicine News:Health News:Michael Unhjem Appointed to Board of Directors for Health Integrated 2Health News:Michael Unhjem Appointed to Board of Directors for Health Integrated 3Health News:Group Health Cooperative Scored Above Regional Average in 11 of 15 Quality Measures 2Health News:Silas Home Care Selects Cardiocom Telehealth Technology 2Health News:Nycomed Announces FDA Filing for Daxas(R) in COPD 2Health News:Nycomed Announces FDA Filing for Daxas(R) in COPD 3Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 2Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 3Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 4Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 5Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 6Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 7Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 8Health News:-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments- 9Health News:Diane Adams Joins Allscripts as Executive Vice President, Human Resources 2Health News:Diane Adams Joins Allscripts as Executive Vice President, Human Resources 3Health News:Diane Adams Joins Allscripts as Executive Vice President, Human Resources 4
(Date:10/1/2014)... 1, 2014  SI-BONE, Inc., a medical device company that ... a minimally invasive surgical (MIS) device indicated for fusion for ... expansion of its European operations with the formation of a ... as General Manager, Germany.  Mr. Schaber will join former Kyphon ... Europe , Middle East ...
(Date:10/1/2014)... Oct. 1, 2014  CVS Health is thanking its ... role in changing the way health care is delivered ... the Company,s retail pharmacies, mail service pharmacies and specialty ... our company name to CVS Health to reflect our ... the innovations needed to shape the future of health," ...
(Date:10/1/2014)... Switzerland , October 1, 2014 ... Genomics and Next Generation Sequencing (NGS) data analysis, today ... run full cystic fibrosis analysis in a single NGS ... characterisation of all types of variants in a single ... Until now, it has not been possible to simultaneously ...
Breaking Medicine Technology:SI-BONE, Inc. Announces European Expansion with Appointment of Eric Schaber as General Manager, Germany and Formation of GmbH 2SI-BONE, Inc. Announces European Expansion with Appointment of Eric Schaber as General Manager, Germany and Formation of GmbH 3SI-BONE, Inc. Announces European Expansion with Appointment of Eric Schaber as General Manager, Germany and Formation of GmbH 4CVS Health Thanking its Pharmacists during American Pharmacists Month for Helping People on Their Path to Better Health 2CVS Health Thanking its Pharmacists during American Pharmacists Month for Helping People on Their Path to Better Health 3Sophia Genetics Launches Full CFTR Analysis in Single Clinical Grade NGS Experiment 2
... and JERUSALEM, Sept. 14, 2011 Chiasma, Inc., a privately ... CEO, will present an overview of the Company at the ... York, New York, on Monday, September 19, 2011 at 1:30 ... oral form of octreotide acetate being developed first for the ...
... Medical Technologies, Inc. and the Physician Services technology ... announced an agreement for INHS to provide Greenway,s ... solution PrimeSUITE® 2011 to hospital systems ... network interoperability. Established more than a ...
Cached Medicine Technology:Chiasma to Present at the UBS Global Life Sciences Conference 2Greenway Partners With INHS to Advance EHR Adoption 2Greenway Partners With INHS to Advance EHR Adoption 3
3 mm disposable bevel blades. Malleable shafts. Blades packaged 6 per package....
Straight 8 mm downcutting Royce blade. Can be placed in closed handle for protection. Rigid handle when folded and locked. Straight 8 mm downcutting blades. Handle length folded 109 mm, 4.3 inches....
2 mm diameter blade. Angled 60 degrees. Sharp. Round handle....
1.25 mm x 2.5 mm blade. 135 degrees back scratcher. Round handle....
Medicine Products: