The Early Clinical Response Endpoint: Great Timing by the Food and Drug Administration?

Author:

Talbot George H.

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

Reference10 articles.

1. Infectious Diseases Society of America. Bad bugs, no drugs: as antibiotic discovery stagnates ... a public health crisis brews. Arlington, VA: IDSA, 2004. Available at: https://www.idsociety.org/uploadedFiles/IDSA/Policy_and_Advocacy/Current_Topics_and_Issues/Advancing_Product_Research_and_Development/Bad_Bugs_No_Drugs/Statements/As%20Antibiotic%20Discovery%20Stagnates%20A%20Public%20Health%20Crisis%20Brews.pdf. Accessed 16 November 2016.

2. US Food and Drug Administration. Antibacterial drug products: use of noninferiority trials to support approval. Silver Spring, MD: FDA, 2010. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070951.pdf. Accessed 18 October 2016.

3. Xconomy. Trius puts the brakes on IPO plan, while it adjusts to new FDA clinical guidelines. 2010. Available at: http://www.xconomy.com/san-diego/2010/03/05/trius-puts-the-brakes-on-ipo-plan-while-it-adjusts-to-new-fda-clinical-guidelines/. Accessed 18 October 2016.

4. Progress on Developing Endpoints for Registrational Clinical Trials of Community-Acquired Bacterial Pneumonia and Acute Bacterial Skin and Skin Structure Infections: Update From the Biomarkers Consortium of the Foundation for the National Institutes of Health

5. US Food and Drug Administration. Guidance for industry: acute bacterial skin and skin structure infections—developing drugs for treatment. Silver Spring, MD: FDA, 2013. Available at: http://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UCM071185.pdf. Accessed 18 October 2016.

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