A collaborative model for endpoint development for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia

Clinical Infectious Diseases

Volumn 55, Issue 8, 2012, Pages 1122-1123

  Toerner, Joseph G ^a   Burke, Laurie ^a   Komo, Scott ^a   Papadopoulos, Elektra ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; CEFTAROLINE FOSAMIL;

ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTION; BACTERIAL SKIN DISEASE; COMMUNITY ACQUIRED PNEUMONIA; DISEASE COURSE; DRUG EFFICACY; EDITORIAL; HUMAN; OUTCOME ASSESSMENT; PRIORITY JOURNAL; SKIN STRUCTURE;

ANTI-BACTERIAL AGENTS; CLINICAL TRIALS AS TOPIC; COMMUNITY-ACQUIRED INFECTIONS; ENDPOINT DETERMINATION; HUMANS; PNEUMONIA, BACTERIAL; SKIN DISEASES, BACTERIAL;

EID: 84866646315     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cis567     Document Type: Editorial

References (5)

1. Talbot GH, Powers JH, Fleming T, et al. Progress on developing endpoints for registrational clinical trials of communityacquired bacterial pneumonia and acute bacterial skin and skin structure infections: update from the Biomarkers Consortium of the Foundation for the National Institutes of Health. Clin Infect Dis 2012; xx; xxx-xxx.
2. The US Food and Drug Administration docket for submission of comments in response to the draft guidance for industry, Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment, is assigned docket number FDA-2010-D-0433. Draft guidance and comments from the FNIH project team. Available at: http://www.regulations.gov/#!docketDetail; dct= FR%252BPR%252BN%252BO%252BSR% 252BPS;rpp=25;po=0;D=FDA-2010-D-0433. Accessed 26 June 2012.
3. The US Food and Drug Administration docket for submission of comments in response to the draft guidance for industry, Community Acquired Bacterial Pneumonia: Developing Drugs for Treatment, is assigned docket number FDA-2009-D-0136. Draft guidance and comments from the FNIH project team. Available at: http://www.regulations.gov/#!docketDetail; dct= FR%252BPR%252BN%252BO%252BSR; rpp=25;po=0;D=FDA-2009-D-0136. Accessed 26 June 2012.
4. US Food and Drug Administration. Guidance for industry, non-inferiority clinical trials. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf. Accessed 26 June 2012.
5. US Food and Drug Administration. Drugs@ FDA. Available at: http://www.accessdata.fda. gov/scripts/cder/drugsatfda/. Accessed 26 June 2012.