FDA perspective on antivirals against biothreats: Communicate early and often

Antiviral Research

Volumn 78, Issue 1, 2008, Pages 60-63

  Roberts, Rosemary ^a   Styrt, Barbara ^a   McCune, Susan ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Animal Rule; Antiviral products; Biothreats; Clinical trials; Drug development; Drugs; Food and Drug Administration (FDA); Highly pathogenic viruses; Therapeutic biologics

Indexed keywords

ANTIVIRUS AGENT;

ANTIVIRAL ACTIVITY; ARTICLE; BIOLOGICAL WARFARE; CLINICAL TRIAL; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; MORTALITY; NONHUMAN; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; VIRUS TRANSMISSION; VIRUS VIRULENCE;

ANIMALS; ANTIVIRAL AGENTS; BIOTERRORISM; DISEASE MODELS, ANIMAL; DRUG APPROVAL; DRUG INDUSTRY; GOVERNMENT REGULATION; HUMANS; INTERDISCIPLINARY COMMUNICATION; PRIVATE SECTOR; PUBLIC SECTOR; THERAPIES, INVESTIGATIONAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VIRUS DISEASES;

ANIMALIA;

EID: 40749131360     PISSN: 01663542     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.antiviral.2007.10.001     Document Type: Article

References (1)

1. Food and Drug Administration, HHS. New Drug and Biological Drug Products: Evidence needed to demonstrate effectiveness of new drugs when human efficacy studies are not ethical and feasible. Federal Register 2002 May 31; 67(105), 37988-37998.