Biologics Development: A Regulatory Overview

Published Nov 01, 2021

Length 464 Pages

SKU # BNT17523517

Description

Originally written by CDER and CBER officials and industry experts, the newly-updated Biologics Development: A Regulatory Overview offers an extensive examination of the FDA’s regulations and guidelines for biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. The book also provides a detailed look inside the approval pathway for today’s biological products along with an analysis of each stage of the biological product development process, including:

CDER organization and processes for regulating and reviewing therapeutic biological products;

CDER’s processes for regulating and reviewing cellular/tissue-based products and gene therapies, vaccines, and blood products.;

How CDER and CBER have evolved their procedures and requirements to address new challenges including risk management priorities and internal agency initiatives.;

Applications of updated ICH GCP E6 and E8 guidelines to biological products development.;

Emerging standards for the clinical and nonclinical testing of biological products, including combination products and biosimilars.

Chapter 1: What is a Biologic?; A Brief History of Biologics Regulation in the United States; Recent Changes in the Government’s Approach to Biologics Regulation; Regulatory Definition of a Biological Product; General Comparison of Drug and Biologic Characteristics; Product Classification and the FDA’s Intercenter Agreements; The Importance of Product Classification: Impact on Development Strategy; The Specter of “Follow-On” Biologics; References
Chapter 2: Preclinical Safety Assessment of Therapeutic Proteins and Monoclonal Antibodies; Preclinical Development of Biologics; Biologics-Specific Concepts; Preclinical Studies to Support the Safety of Biologics; The Timing of Preclinical Studies Relative to Clinical Trials; Summary; References
Chapter 3: The Biological IND; FDA Organization and IND Submissions; Types of IND Submissions; Before Submitting an IND; Example Meeting Request Sheet; The Original IND Submission; Contents of the IND; INDs for Gene Therapies; The Submission and Review of the IND; Amendments to the IND; Electronic INDs; Summary; Acknowledgments; References
Chapter 4: The Biological IND Review Process; The FDA and Regulating Biological Products: Recent History and Agency Structure; FDA Announces CDER/CBER Consolidation; A Look at the Structure of CBER and CDER for IND Reviews; CBER Structure; The Office of Tissues and Advanced Therapies (formerly known as Office of Cellular, Tissue and Gene Therapies).82; CDER’s Structure for Biological IND Reviews; The Review Process for INDs; CBER and the IND Review Process; CDER and the IND Review Process for Biological Therapeutic Products; The IND and the 30-Day IND Review Clock; The Clinical Hold; IND Status; Biologics Development: A Regulatory Overview; viii Published by:
Chapter 5: Clinical Testing of Biologically Derived Therapeutics; Phases of Clinical Drug Development; References
Chapter 6: The Clinical Evaluation of Preventive Vaccines; Federal Regulations Pertaining to Vaccines; U.S. FDA Regulations Relevant to the Manufacture,; Product Quality and Clinical Testing of Vaccines*; Overview of Clinical Evaluation; Phases of Clinical Development; Serious Adverse Events (SAEs) During Clinical Development; Additional Considerations for Safety Data; FDA Advisory Committee Deliberations; Postlicensure Studies; Postlicensure Surveillance; Regulatory Initiatives for Accelerated Vaccine Development During COVID-19 Pandemic; Acknowledgments; References
Chapter 7: Good Clinical Practices (GCP); Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators; Responsibilities of the Sponsor; Responsibilities of Investigators; The Institutional Review Board (IRB); Informed Consent; References
Chapter 8: The Biological License Application (BLA); A Short History of the FDA’s Licensing Process for Biologics; An Introduction to the BLA: Content and Format Requirements and Form 356h; The Content of the BLA; CBER and the eBLA Program; Amending the License Application; References
Chapter 9: Manufacturing Arrangements For Biological Products; Biologics Establishment Registration; Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) Establishments; The Biotech Explosion, Industry Consolidation, and Biological Manufacturing; The FDA Redefines “Manufacturer”; Sole Manufacturing; Current Cooperative Manufacturing Arrangements for Licensed Biologics; Facility Inspections; References; Table of Contents; Published by: ix
Chapter 10: The Biological License Application (BLA) Review Process; The BLA Review Process; The BLA Managed Review Process Within CBER; Sponsor Rights during the License Application Review Process; References
Chapter 11: Post-licensure Requirements; Adverse Experience-Related Regulatory Definitions; Changes in AE Reporting Requirements; Expedited Reporting of Additional Safety Information; Lot Release; Current Good Manufacturing Practice (cGMP) Standards for Biological Products; Written Procedures for the investigation should include the following:; Written records of the investigation should include:; General Reporting Requirements; Phase 4 Study Commitments; References
Chapter 12: Bioresearch Monitoring Program for Biologics; A Brief History of the Bioresearch Monitoring Program; Recent Issues for the FDA’s BIMO Program; An Overview of CBER’s Bioresearch Monitoring Program; The Clinical Investigator Compliance Program; The Clinical Sponsor/Monitor Compliance Program; The Institutional Review Board (IRB) Compliance Program; The Nonclinical Laboratory Compliance Program; CDER’s Bioresearch Monitoring Program; References
Chapter 13: Biologics and the Regulation of Combination Products; Defining Biologics, Drugs, and Devices; CBER Action Plans; Combination Products and Gaining CBER Approval; Safe Medical Devices Act (SMDA) of 1990; Table. RFD Determinations by OCP and Workload Trends: FY 2013 to FY 2018; Table. Workload at OCP by Combination Product Category Number in FY 2018. Combination; PDUFA and Various Classes of CBER-Regulated Products; Risk–Based Quality and Safety Management throughout the Lifecycle of Combination Products; References
Chapter 14: Special Topics in the Development of Biologically Derived Therapeutics; References; Biologics Development: A Regulatory Overview; x Published by:
Chapter 15: Biosimilar Products; Biosimilar Development, Review, and Approval Processes; Interchangeable Products: Definition, Regulatory Review and Approval Process; Post-marketing or Post-authorization Surveillance Requirements; Nomenclature; FDA-Approved Biosimilar Products; The Biologics Price Competition and Innovation Act; An Abbreviated Approval Pathway for Biological Products; References; About Barnett International; About Cambridge Healthtech Institute

Pricing

Currency Rates

Single User Email from Publisher $195

How Do Licenses Work?

Request A Sample

Questions or Comments?

Our team has the ability to search within reports to verify it suits your needs. We can also help maximize your budget by finding sections of reports you can purchase.

Chat Now