Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation

Guidance for Industry
Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact Fred Marsik at 301-796-0756.

abrir aquí para bajar el archivo PDF:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM182288.pdf