Recently Posted Guidance Documents on ICH-Quality, Clinical - Medical, Biologics, and Clinical - Antimicrobial

ICH-Quality 7/13/2018  Q3D(R1) ELEMENTAL IMPURITIES Clinical - Medical 7/13/2018  Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for Industry Biologics 7/11/2018  Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry 7/11/2018  Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry 7/11/2018  Long Term Follow-up After Administration of Human Gene Therapy Products; Draft Guidance for Industry 7/11/2018  Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft Guidance for Industry 7/11/2018  Human Gene Therapy for Rare Diseases; Draft Guidance for Industry 7/11/2018  Human Gene Therapy for Hemophilia; Draft Guidance for Industry Clinical - Antimicrobial 7/10/2018  Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention Guidance Document Search Search all FDA official guidance documents and other regulatory guidance