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Cellular Therapies - Comments

Comments to FDA on “Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Extension of Comment Periods" - 9/26/16

Comments to FDA on "Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Deviations in Manufacturing" - 8/10/16

Comments to FDA on “Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry" - 3/31/16

Comments to FDA, Pertinent to Cellular Therapies, on Proposed Rule “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products” - 5/18/15

Comments to FDA on Draft Guidance “Current Good Manufacturing Practice Requirements for Combination Products” - 4/29/15

Comments to FDA on Draft Guidance “Investigating and Reporting Adverse Reactions Related to HCT/Ps Regulated Solely under Section 361 of the PHS Act and 21 CFR Part 1271” - 4/21/15

Comments to FDA on Draft Guidance for Industry: “Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations" – 2/23/15

Comments to FDA on Draft Guidance for Industry “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff” - 2/23/15

Comments to FDA on Draft Guidance for Industry: "Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception" - 12/22/14 

Comments to FDA on "Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products" - 5/8/14

Comments to FDA on "Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection With Treponema pallidum (Syphilis)" - 1/31/14

Comments to FDA on "Draft Guidance for Industry: Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products" – 1/21/14

Comments to FDA on the Proposed Rule “Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products" – 1/3/14

Comments to FDA on the Draft Guidance "Preclinical Assessment of Investigational Cellular and Gene Therapy Products." – 2/26/13

Comments to FDA on the "Unique Device Identification System" – 11/07/12

Comments to FDA on "Bar Code Technologies for Drugs and Biological Products; Retrospective Review Under Executive Order 13563; Request for Comments" – 1/9/12

General Comments