Bibliography

Organizational Overview

Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-Up of Patients in Clinical Trials Using Retroviral Vectors—11/28/2006

Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)—11/8/2004

Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)—8/15/2003

Guidance for Industry: Guidance for Human Somatic Cell Therapy and
Gene Therapy—3/30/1998

Cellular & Gene Therapy Meeting Information

Xenotransplantation Publications

Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans—4/3/2003

Human Cells or Tissues Intended for Transplant Into a Human Recipient
That Have Ex-Vivo Contact With Live Nonhuman Animal Cells, Tissues, or Organs Letter—3/8/2002

Information and Recommendations for Physicians Involved in the Co-Culture of Human Embryos with NonHuman Animal Cells—3/8/2002

Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts—2/1/2002

PHS Guideline on Infectious Disease Issues in Xenotransplantation—1/19/2001

Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals—7/19/1993

References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies (OCTGT)

Center for Drug Evaluation and Research (CDER)

Office of Oncology Drug Products

Office of Biotechnology Products

Critical Path Role in Product Development

Overview of Regulatory Information

Regulatory Requirements and Recommendations

Acts, Regulations, and Guidances

Federal Food, Drug, and Cosmetic Act

Public Health Service Act

Code of Federal Regulations—Biologics Related

CBER Guidances/Guidelines/Points to Consider

CDER Guidances

Policies and Procedures

CBER Manual of Regulatory Standard Operating Procedures and Policies

CDER Manual of Policies and Procedures (MaPP)

Submitting an Investigational New Drug (IND)

Biological Product: Information on Submitting an IND Application to CBER

IND Application Process for CDER

Practical and Organizational Issues for PI-Initiated Projects

NCI RAID Request for Applications Notices

Guidelines for Submitting an NCI RAID Application

RAID Process and Procedures Document

Instructions for Using the RAID Online Submission Application

Biological Resources Branch, DTP, DCTD, NCI

Technology Transfer Branch, NCI

NCI RAID Material Transfer Agreements

NCI RAID Clinical Material Transfer Agreement

RAID Technology Transfer Form (Intellectual Property Form)

The Sponsor's Guide to Regulatory Submissions for an Investigational New Drug

Preclinical and Nonclinical Testing

Nonclinical Safety Testing for Biological Therapeutics for Cancer Treatments

Guidance for Industry: M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (pdf)

Guideline for Industry: ICH S5A Detection of Toxicity to Reproduction for Medicinal Products (pdf)

Guidance for Industry: ICH S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (pdf)

Guidance for Industry: S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (pdf)

Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use

Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals

Perspective on Pharm/Tox Assessment for Cell and Gene Therapy Products

Guidance for Industry: Gene Therapy Clinical Trials—Observing Subjects for Delayed Adverse Events—11/28/2006

Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products—5/1998 (pdf)

Guidance for Industry: Guidance for Human Somatic Cell Therapy and
Gene Therapy—3/30/1998

The ICH S6 Document: Preclinical Safety Evaluation of Biotechnology Derived Pharmaceuticals—7/1997 (pdf)

Clinical Trials

Good Clinical Practice in FDA-Regulated Clinical Trials

Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance (pdf)

Clinical Investigator Information

FDA Regulations Relating to Good Clinical Practice and Clinical Trials

Guidance for Industry: Gene Therapy Clinical Trials—Observing Subjects for Delayed Adverse Events—11/28/2006

Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies—1/12/2006

Manufacturing

Manufacturing of Cellular and Gene Therapies

References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies—4/27/2006

Guidance for Industry: INDs—Approaches to Complying with CGMP
During Phase 1—1/2006

Guidance for Industry: Content and Format of Investigational New Drug
Applications for Phase I Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology Derived Products (1995)—11/1995 (pdf)

Guidance for Industry for the Submission of CMC Information for a
Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody
Product for In Vivo Use—8/1996

FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived Products (1996)

Guidance for Industry: INDs—Approaches to Complying with CGMP
During Phase 1—1/2006

Points to Consider in the Manufacture and Testing of Monoclonal Antibody
Products for Human Use—2/28/1997

Points to Consider in the Characterization of Cell Lines Used to Produce
Biologicals—7/12/1993 (pdf)

Case Studies

SOPP 8007 DCC Binding Procedures for Regulatory Documents

Regulatory Submissions in Electronic Format

Guidance for Industry: Formal Meetings With Sponsors and Applicants for
PDUFA Products

Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed
Drug or Biological Products for the Treatment of Cancer (pdf)

Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

U.S. Department of Health and Human Services, National Institutes of Health