FDA Releases Guidance on the Treatment of CABP - - BioPharm International

ADVERTISEMENT

FDA Releases Guidance on the Treatment of CABP


FDA has released Guidance for Industry, Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment, Draft Guidance to assist sponsors in the clinical development of drugs for the treatment of community-acquired bacterial pneumonia (CABP). The guidance addresses development program and clinical trial designs for drugs to support an indication for the treatment of CABP and is intended to serve as a focus for continued comments and discussions among the Division of Anti-Infective Products, pharmaceutical sponsors, the academic community, and the public.

This guidance does not contain discussion of the general issues of statistical analysis or clinical trial design. Those topics are addressed in the ICH guidance for industry E9 Statistical Principles for Clinical Trials and E10 Choice of Control Group and Related Issues in Clinical Trials, respectively.

This guidance revises a 2009 guidance, Pneumonia: Developing Drugs for Treatment.

Source: FDA.gov

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Amgen, Sanofi, and Ono Pharmaceuticals Partner with Universities on Transmembrane Protein Research
October 28, 2014
Yale and Gilead Extend Sequencing Initiative
October 28, 2014
Contract Research and Manufacturing Organization Paragon Bioservices Raises $13 Million
October 28, 2014
Novartis Sells Influenza Vaccine Business to CSL for $275 Million
October 27, 2014
Author Guidelines

Click here