FDA Releases Pulmonary Tuberculosis Guidance - - BioPharm International

ADVERTISEMENT

FDA Releases Pulmonary Tuberculosis Guidance


FDA has released a draft guidance, Pulmonary Tuberculosis: Developing Drugs for Treatment, to assist sponsors in the clinical development of drugs for the treatment of pulmonary tuberculosis. The guidance document addresses the overall development program and clinical trial designs for drugs to support an indication for the treatment of active pulmonary tuberculosis. The guidance applies to the development of a single investigational drug as well as to the development of two or more new investigational drugs for use in combination.

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