S9 Guideline: S9 Implementation Working Group: Nonclinical Evaluation for Anticancer Pharmaceuticals: Questions and Answers QPS S9 Guideline: S9 Implementation Working Group: Nonclinical Evaluation for Anticancer Pharmaceuticals: Questions and Answers Read More »
Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment QPS Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment Read More »
Drug Products, Including Biological Products, that Contain Nanomaterials QPS Drug Products, Including Biological Products, that Contain Nanomaterials Read More »
Draft Guidance on Doxorubicin Hydrochloride QPS Draft Guidance on Doxorubicin Hydrochloride Read More »
Liposome Drug Products: Chemistry, Manufacturing, and Controls: Human Pharmakinetics and Bioavailability; and Labeling Documentation QPS Liposome Drug Products: Chemistry, Manufacturing, and Controls: Human Pharmakinetics and Bioavailability; and Labeling Documentation Read More »
Expedited Programs for Serious Conditions – Drugs and Biologics QPS Expedited Programs for Serious Conditions – Drugs and Biologics Read More »