Recently Posted Guidance Documents

Recently Posted Guidance Documents

1/30/2020 - Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims 1/30/2020 - Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry 1/28/2020 - Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff 1/28/2020 - Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry 1/28/2020 - Human Gene Therapy for Hemophilia: Guidance for Industry 1/28/2020 - Human Gene Therapy for Rare Diseases: Guidance for Industry 1/28/2020 - Human Gene Therapy for Retinal Disorders: Guidance for Industry 1/28/2020 - Long Term Follow-up After Administration of Human Gene Therapy Products: Guidance for Industry 1/28/2020 - Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up: Guidance for Industry 1/27/2020 - Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Draft Guidance for Industry