Navigation Links
New Critical Path Report Highlights Research Needed to Foster,Generic Drug Development

will be withdrawn from the market after 2008. The new report will help ensure FDA has an adequate scientific basis to review inhaler applications that use an alternative, hydrofluoroalkane.

The report also calls for research on new bioequivalence methods tailor-made for each challenging drug class. These include lung function tests and molecular level imaging for inhalation drugs; particle size distribution tests for nasal sprays; and methods for direct measurement of drug delivered to the skin.

In addition, the report highlights possible research projects that might lead to new modeling and simulation tools for drug absorption, drug release and other drug development issues and to alternative methods for seeking waivers from clinical bioequivalence studies.

Last year FDA issued the Critical Path Opportunities Report listing 76 specific scientific projects that, if undertaken, would help modernize the Critical Path sciences. This companion document focuses more narrowly on the scientific challenges unique to the development of generic drugs.

To learn more about the Critical Path Initiative consult:
www.fda.gov/oc/initiatives/criticalpath/

Information on FDA's Generic Drug Office is available at:
www.fda.gov/cder/ogd/index.htm.

####

Media Inquiries:
Karen Riley, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


'"/>




Page: 1 2

Related medicine technology :

1. NIEHS Researchers Identify Enzyme Critical in DNA Replication
2. Velcade (bortezomib) for Injection Based Induction Therapy Delivered High Post-Transplant Complete Remission Rate, a Critical Marker for Increased Overall Survival
3. Critical Therapeutics Announces the Publication of Data for ZyfloCR (Zileuton) Extended-Release Tablets in the Journal of Asthma
4. Critical Therapeutics Announces the Publication of New Preclincial HMGB1 Data in Nature Immunology
5. Data Show SuperGens Multi-Targeted Tyrosine Kinase Inhibitor Suppresses Critical Double-Stranded DNA Repair Protein, Rad51
6. MIV Therapeutics Announces Pivotal Test Results Further Validating Company Stent Coatings Meet Critical FDA Fatigue Guidelines
7. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
8. Gene Therapy Eradicates Pancreatic Cancer in Preclinical Trial Targeting Systems Success in Mouse Model Reported in Cancer Cell
9. Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis
10. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
11. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
Post Your Comments:
(Date:12/4/2009)..., , RARITAN, N.J., Dec. 4 ...ttention Deficit Hyperactivity Disorder (ADHD), sl...orbidities reported to occur more often in people ...sus those without an epilepsy diagnosis, according...cross the U.S. ,, Findings from " CNS-Related C...
(Date:12/3/2009)..., , MADISON, N.J., Dec. 3 /PRNewswire-Fir... patient,s risk of developing a potentially life-t...armaceutical therapies or chemicals is one of seve...ostics leader Quest Diagnostics (NYSE: DGX ) wil...tology (ASH) Annual Meeting and Exposition, Decemb...
(Date:12/3/2009)..., , WARRENDALE, Pa., Dec. 3 /PRN...demonstrated PACS* injection-record integration ca...of North America in Chicago. The Connect.PACS(TM...cs capabilities of its kind, is the latest release...rmatics Platform . ,, (Photo: http://www.ne...
Breaking Medicine Technology:Looking Ahead to AES 2009: New Insights on Comorbidities and Other Considerations for Epilepsy Treatment 2Looking Ahead to AES 2009: New Insights on Comorbidities and Other Considerations for Epilepsy Treatment 3Quest Diagnostics Reveals New Genetic Discoveries for Testing for Leukemia, Lymphoma and Blood Clotting at 51st ASH Meeting and Exposition 2Quest Diagnostics Reveals New Genetic Discoveries for Testing for Leukemia, Lymphoma and Blood Clotting at 51st ASH Meeting and Exposition 3MEDRAD Demonstrates PACS Injection-Record Integration at RSNA 2009 2MEDRAD Demonstrates PACS Injection-Record Integration at RSNA 2009 3Orexigen 28R 29 Therapeutics Phase 2b Trial for Empatic 28TM 29 Meets Primary Efficacy Endpoint Demonstrating Significantly Greater Weight Loss Versus 58518 1Orexigen 28R 29 Therapeutics Phase 2b Trial for Empatic 28TM 29 Meets Primary Efficacy Endpoint Demonstrating Significantly Greater Weight Loss Versus 58518 2Orexigen 28R 29 Therapeutics Phase 2b Trial for Empatic 28TM 29 Meets Primary Efficacy Endpoint Demonstrating Significantly Greater Weight Loss Versus 58518 3Orexigen 28R 29 Therapeutics Phase 2b Trial for Empatic 28TM 29 Meets Primary Efficacy Endpoint Demonstrating Significantly Greater Weight Loss Versus 58518 4Orexigen 28R 29 Therapeutics Phase 2b Trial for Empatic 28TM 29 Meets Primary Efficacy Endpoint Demonstrating Significantly Greater Weight Loss Versus 58518 5Orexigen 28R 29 Therapeutics Phase 2b Trial for Empatic 28TM 29 Meets Primary Efficacy Endpoint Demonstrating Significantly Greater Weight Loss Versus 58518 6Edifecs 28TM 29 Provides Free Commercial Off The Shelf 28COTS 29 Solution for Medicare Administrative Contractors 28MACs 29 58515 1Edifecs 28TM 29 Provides Free Commercial Off The Shelf 28COTS 29 Solution for Medicare Administrative Contractors 28MACs 29 58515 2Sinovac Obtains Second Order of H1N1 Vaccine from Chinese Central Government 58512 1Sinovac Obtains Second Order of H1N1 Vaccine from Chinese Central Government 58512 2Sinovac Obtains Second Order of H1N1 Vaccine from Chinese Central Government 58512 3
(Date:12/4/2009)...ec. 4 Care Investment T...) today announced that its Board of Directors has ...tock. The dividend is payable on December 22, 200... 2009. ,, About Care Investment Trust ,...stment and finance company investing in healthcare...
(Date:12/4/2009)...ISCO, Dec. 4 Medithrive, Inc. has ...pensary in the SF Bay Area by popular vote conduct...ite only three months in operation, the SF Bay com...ocation for accessing medicinal marijuana. ,,...rms the obvious: a dispensary which caters to the ...
(Date:12/4/2009)... Dec. 4 The American As...SA) applauds the Senate for ensuring that the Com...isions remain in the final health reform legislati...ing support to elders, people with disabilities an...ass a health care reform bill that will make it af...
(Date:12/4/2009)...TY, Mo., Dec. 4 The large, two-day...ciation of Free Clinics (NAFC) in Kansas City on W... also for anyone who is uninsured and has not seen... clinic will receive preventive primary care. ,...rge free clinic events this fall in Houston, New O...
(Date:12/4/2009)... Calif., Dec. 4 Pamela Bowen, Chie...selected as a finalist for the "Chief Innovation O...iness with the power of cloud computing. Appy Awar...ve usage of Salesforce CRM or the Force.com platfo...heir sales, marketing, partner, service, support o...
Breaking Medicine News(10 mins):Health News:Care Investment Trust Inc. Declares Quarterly Dividend of $0.17 Per Share 2Health News:Free Health Clinic Event Is Not Just for the Sick 2Health News:Crescent CIO '09 Dreamforce Conference Speaker and Award Finalist 2
...oung people appear to be developing the most commo...a dramatic increase in the cost and suffering //ca... overexposure to ultraviolet light from the sun, u...almost always curable and that together afflict 1 ...
... years since the Transplantation of Human Organ Ac...ay with the programme. This has been due to variou...irection and the will to seriously consider this a...idney scandal there is a knee jerk reaction from v...
...ug Digoxin or Digitalis, which comes from the foxg...t efficiently by maintaining the rhythm of the hea...f the drug is changed by the team of researchers f... which works by changing the sugars attached to th...
...s have shown that the efficacy of low-carb diets c... researchers question whether raising protein inta...cent study researchers set out to test the hypothe...ight loss. However some are of the opinion that pr...
...se are crucial factors. But according to the resea...reventive Medicine, // it has been found that calo...ath by heart disease. The finding was based on... done from 1971 to 1975. The participants were gro...
...ould not be a factor in determining transplant el...hown that older heart transplant patients do just ...archers evaluated all 275 adult patients who recei...o 11 years following surgery. Results showed no st...
Other Medicine News:Health News:The Potential Of Cadaver Transplantation Programme In India 2Health News:The Potential Of Cadaver Transplantation Programme In India 3Health News:Finding The Key To Weight Loss! 2
Plasmacup SC
Trabecular Metal Modular Acetabular System
BiHAPro Acetabular Cup
Gap II Revision Cup
Medicine Products: