FDA Sets Guidance Agenda

Washington, DC (Sept. 1) - In a Federal Register announcement (Fed. Regist. 71(170), 52125-52136, Sept. 1, 2006), the US Food and Drug Administration laid out its guidance agenda for the coming months, along with a request for comments and comment contacts-while cautioning that "the agency is neither bound by this list of possible topics nor  required to issue every guidance document on this list or precluded from issuing guidance documents not on the list set forth in this  document."
The announcement lists dozens of potential topics. Those relevant to manufacturing include:

Center for Drug Evaluation and Research (CDER)

• Immunogenicity Assessment for Follow-on Protein Products

• Immunogenicity Assessment for Therapeutic Protein Products

• Individual Product Bioequivalence Recommendations

• Patient Specific Drug Products

• Quality by Design

• Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes

• Registration Requirements Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

• Process Validation: General Principles and Practices

• Penicillin as Defined in the CGMP Regulation Under 21 CFR 211 and Separation Requirements for Manufacturing

• Non-Penicillin Beta-Lactam Contamination

• Importation of Active Pharmaceutical Ingredients

• Providing Regulatory Submissions in Electronic Format--Analysis Datasets and Documentation

• Good Meeting Management Guidance

Center for Biologics Evaluation and Research (CBER)

• Design, Operation, and Validation of Heating, Ventilation, and Air Conditioning (HVAC) Systems Used in the Manufacture of Products Regulated by the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research

• Characterization and Qualification of Cell Substrates and Other Biological Starting Materials for the Production of Viral Vaccines

• Devices Involved in Manufacture, Storage and Administration of Cellular Products and Tissues

• Validation of Rapid Microbiological Methods for Assessing Sterility of Cellular and Gene Therapy Products

• Facilities and Controls for Cellular and Gene Therapy Product Manufacturing Operations Guidance

• Changes to an Approved Application: Biological Products

Center for Veterinary Medicine (CVM)

• Chemistry, Manufacturing, and Control Changes to an Approved Veterinary Medicine (HFV-143), NADA or ANADA (83)

• Veterinary Drug Compounding Compliance Policy Guide

• Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions

• International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH):
• GL-39 Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances

• GL-40 Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/ Biological Veterinary Medicinal Products

• Draft Revised Guidance for Industry on Impurities in New Veterinary Drug Substances (Revision) VICH GL10(R)

• Draft Revised Guidance for Industry on Impurities in New Veterinary Medicinal Products (Revision) VICH GL11(R)

• GL-24 Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports

• GL-42 Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports

• GL-29 Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)

• GL-30 Pharmacovigilance of Veterinary Medicinal Products: Controlled Lists of Terms

Office of Regulatory Affairs (ORA)

• Untrue Statements of Material Facts