FDA Releases Guidance on the Treatment of CABP - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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FDA has released Guidance for Industry, Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment, Draft Guidance to assist sponsors in the clinical development of drugs for the treatment of community-acquired bacterial pneumonia (CABP).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

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
29%
Oversee medical treatment of patients in the US.
11%
Provide treatment for patients globally.
7%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics

Click here