Meeting the challenges of medical countermeasure development

Author:

Maher Carmen1,Hu-Primmer Jean1,MacGill Tracy1,Courtney Brooke1,Borio Luciana1

Affiliation:

1. FDA, Medical Countermeasures Initiative (MCMi); Silver Spring MD USA

Publisher

Wiley

Subject

Applied Microbiology and Biotechnology,Biochemistry,Bioengineering,Biotechnology

Reference23 articles.

1. Reinventing Project BioShield;Cohen;Science,2011

2. Department of Health and Human Services 2010 Assistant Secretary for Preparedness and Response https://www.medicalcountermeasures.gov/media/1138/mcmreviewfinalcover-508.pdf

3. The cost of biopharmaceutical R&D: is biotech different? John Wiley & Sons, Ltd.;DiMasi;Managerial and Decis Econ,2007

4. Food and Drug Administration 2009 Draft guidance for industry, essential elements to address efficacy under the animal rule http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078923.pdf

5. Food and Drug Administration 2010a Advancing Regulatory Science Initiative http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/default.htm

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