CDER New February 25, 2013

Guidance for Industry:

• Labeling for Human Prescription Drug and Biological Products -- Implementing the PLR Content and Format Requirements (PDF - 527KB)
• http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075082.pdf?source=govdelivery
• Attachment to: Guidance on Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data  (PDF - 391KB)
• http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM340712.pdf?source=govdelivery