the archives
White papers & issue briefs
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"Recent FDA Requests to Validate User Interface Specifications for Drug and Biologic-led Combination Products"
October 2022 - CPC’s Human Factors Working Group issued a white paper entitled "Recent FDA Requests to Validate User Interface Specifications for Drug and Biologic-led Combination Products."
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"Issue Summary: Cross Labeled Combination Products"
August 2020 - CPC issued a white paper on "Proposed Cross-Labeling/Combined Use Guidance Considerations."
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"Industry Perspective of US Combination Product Rule: Postmarket Safety Reporting Challenges and Proposed Solutions"
June 2017 - CPC’s Postmarket Safety Working Group published a white paper entitled "Industry Perspective of US Combination Product Rule: Postmarket Safety Reporting Challenges and Proposed Solutions."
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"Clinical Trial Q&A" Issue Brief
May 11, 2012 - CPC issued its "Clinical Trial Q&A" Issue Brief
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"FDA Regulation of Combination Products - Issue Brief"
April 10, 2012 - CPC issued its “FDA Regulation of Combination Products - Issue Brief.”
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"Injector Systems Human Factors Topics"
December 14, 2012 - CPC issued a white paper entitled "Injector Systems Human Factors Topics."
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"Increasing Focus on Combination Products"
June 8, 2009 - CPC issued a white paper entitled "Increasing Focus on Combination Products."
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"Combination Products: Proposed Policies to Enhance the FDA Regulatory Process"
April 2, 2004 - CPC issued a white paper entitled “Combination Products: Proposed Policies to Enhance the FDA Regulatory Process.”
COMMENT LETTERS TO FDA
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September 30, 2024 - CPC's Comments on FDA's EDDO Draft Guidance
CPC submitted comments in response to FDA’s “Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products” (“EDDO”) Draft Guidance.
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SEPTEMBER 9, 2024 - CPC'S COMMENTS ON FDA'S DRAFT GUIDANCE ON USE-RELATED RISK ANALYSES
CPC's Human Factors Working Group submitted comments in response to FDA's "Purposes and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products" Draft Guidance.
Docket # FDA-2024-D-2484
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AUGUST 16, 2024 - CPC's COMMENTS ON FDA'S Platform Technology Designation Program DRAFT GUIDANCE
CPC's Submissions Working Group submitted comments in response to FDA’s Draft Guidance for the Platform Technology Designation Program, which addresses leveraging data and prior knowledge when scientifically justified and legally permissible.
Docket # FDA-2024-D-1829
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June 25, 2024 - CPC'S cOMMENTS ON OPPOTUNITIES AND PRIORITIES FOR FDA'S OFFICE OF CLINICAL PHARMACOLOGY
CPC’s Bridging Working Group led the submission of a comment letter in response to FDA’s request for comments on “Promoting Effective Drug Development: Identifying Opportunities and Priorities for the FDA’s Office of Clinical Pharmacology.”
Docket # FDA-2024-N-1592
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March 4, 2024 - CPC's Comments on FDA's “Draft Report and Plan on Best Practices for Guidance”
CPC submitted a comment to the FDA's “Draft Report and Plan on Best Practices for Guidance.” The CPC strongly supports FDA moving forward with publication of an annual Guidance Agenda for OCP that lays out OCP's plans for guidance document development and revisions for the upcoming year.
Docket # FDA-2023-N-5653
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December 18, 2023 - CPC'S COMMENTS ON FDA'S DRAFT GUIDANCE ON PRESCRIPTION DRUG USE-RELATED SOFTWARE
CPC submitted comments in response to FDA’s “Regulatory Considerations for Prescription Drug Use- Related Software” draft guidance.
Docket # FDA-2023-D-2482
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June 27, 2023 - CPC'S COMMENTS ON EPA'S PROPOSED REGULATION OF ETHYLENE OXIDE (ETO) EMISSIONS
CPC submitted comments to two Environmental Protection Agency dockets related to proposed regulation of ethylene oxide (EtO) emissions. CPC's goal in submitting the comments is to raise awareness within EPA (and FDA) of the potential impact that restricting the use of EtO may have on the pharmaceutical and biotechnology industry, particularly in relation to drug delivery combination products and sterilization of medical device constituent parts.
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June 21, 2023 - CPC's Comments on FDA’s draft guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions
The CPC submitted a comment letter to FDA in response to its draft guidance titled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions."
Docket # FDA-2022-D-2628
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November 14, 2022 - CPC's Comments on FDA's Computer Software Assurance Draft Guidance
CPC submitted comments on FDA’s “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers Guidance for Industry and Food and Drug Administration Staff” dated October 22, 2019.
Docket # FDA-2022-D-0795
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November 14, 2022 - CPC's Comments on FDA's Prescription Drug User Fee Act VII Solicitation for Comments
CPC submitted comments in response to FDA's "Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Statement of Work; Request for Comments."
Docket # FDA-2022-N-2335
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July 6, 2022 - CPC's Comments on FDA's Cybersecurity in Medical Devices Draft Guidance
CPC submitted comments in response to FDA's "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff."
Docket # FDA-2021-D-1158
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May 24, 2022 - CPC's Comments on QSR Amendments
CPC submitted comments in response to FDA's "Medical Devices; Quality System Regulation Amendments."
Docket # FDA-2021-N-0507
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March 22, 2022 - CPC's Comments on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
CPC submitted comments in response to FDA's "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders."
Docket # FDA-2021-D-1128
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February 1, 2022 - CPC's Comments on the Contents of Premarket Submissions for Device Software Functions
CPC submitted comments in response to FDA's "Content of Premarket Submissions for Device Software Functions; Draft Guidance for Industry and Food and Drug Administration Staff.”
Docket # FDA-2021-D-0775
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July 19, 2021 - CPC's Comments on ICH Q12 Implementation Considerations Guidance
CPC submitted comments in response to FDA's "ICH Q12: Implementation Considerations for FDA-Regulated Products” Draft Guidance.
Docket # FDA-2021-D-0166
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July 12, 2021 - CPC'S COMMENTS ON HEALTH CANADA'S DRUG-DEVICE COMBINATION PRODUCTS DRAFT FOR CONSULTATION
CPC submitted comments in response to Health Canada's "Issue Identification Paper: Drug-Device Combination Products (DDCPs) Draft for Consultation."
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April 6, 2021 - CPC's Comments on FDA's Human Gene Therapy Draft Guidance
CPC submitted comments in response to FDA's "Human Gene Therapy for Neurodegenerative Diseases” Draft Guidance.
Docket # FDA-2020-D-2101
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December 14, 2020 - CPC's Comments on FDA's Biocompability Draft Guidance
CPC submitted comments in response to FDA's "Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin” Draft Guidance.
Docket # FDA-2013-D-0350
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September 28, 2020 - CPC's Comments on the Integrated Review Template
CPC submitted comments on FDA’s "New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation" Template.
Docket # FDA-2020-N-1550
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June 22, 2020 - CPC's Comments on FDA's Emergency Use Injector Draft Guidance
CPC submitted comments on FDA’s “Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA” Draft Guidance dated April 22, 2020.
Docket # FDA-2019-D-5573
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May 18, 2020 - CPC's Comments on Restricted Delivery Systems
CPC submitted comments on FDA’s “Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry” dated March 2020. CPC asked FDA to further clarify the designation of restricted delivery systems, including whether they are considered medical devices, which is a part of the drug container closure system/package or combination products. CPC also asked that the FDA update the Draft Guidance to provide considerations for manufacturers to address during their risk-based development activities and revise the sections which appear to be defining requirements.
Docket # FDA-2020-D-0567
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February 24, 2020 - CPC's Comments on FDA's CPAM Guidance
CPC submitted comments on FDA’s “Requesting Food and Drug Administration Feedback on Combination Products” Draft Guidance dated December 26, 2019, and provided feedback on FDA’s efforts to enhance clarity and transparency of regulatory considerations for combination products through the publication of the Draft Guidance outlining the feedback mechanisms available to sponsors.
Docket # FDA-2019-D-4739
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January 29, 2020 - CPC's Comments on FDA's Manufacturer Site Guidance
CPC submitted comments to FDA's "Identification of Manufacturing Establishment in Applications Submitted to CBER and CDER Questions and Answers” Guidance.
Docket # FDA-2013-S-0610
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December 26, 2019 - CPC's Comment on FDA's "Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software" Draft Guidance
CPC submitted comments in response to FDA's "Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software" Draft Guidance.
Docket # FDA-2019-D-4258
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December 20, 2019 - CPC's Comments on FDA's "Clinical Decision Support Software" Draft Guidance
CPC submitted comments in response to FDA's "Clinical Decision Support Software" Draft Guidance.
Docket # FDA-2017-D-6569
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August 28, 2019 - CPC's Comments on FDA's "Instructions for Use-Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products" Draft Guidance
CPC submitted comments in response to FDA's "Instructions for Use-Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products-Content and Format" Draft Guidance.
Docket # FDA-2019-D-1615
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August 26, 2019 - CPC's Comments on FDA's "New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication" Draft Guidance
CPC submitted comments in response to FDA's "New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication" Draft Guidance.
Docket # FDA-2019-N-2012
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May 31, 2019 - CPC's Comments on FDA's Proposed Regulatory Framework for Modifications to AI/ML-Based SaMD Discussion Paper
CPC submitted comments in response to FDA's "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Devise (SaMD) - Discussion Paper and Request for Feedback" Draft Guidance.
Docket # FDA-2019-N-1185
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May 6, 2019 - CPC's Comments on FDA's "Principles of Premarket Pathways for Combination Products" Draft Guidance
CPC submitted comments in response to FDA's "Principles of Premarket Pathways for Combination Products" Draft Guidance.
Docket # FDA-2019-D-0078
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April 9, 2019 - CPC's Comments on CDER's "Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality" Draft Guidance
CPC submitted comments in response to the Center for Drug Evaluation and Research's "Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality" Draft Guidance.
Docket # FDA-2018-D-4417
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March 7, 2019 - CPC's Comments on FDA's "Medical Device De Novo Classification Process" Proposed Rule
CPC submitted comments in response to "Medical Device De Novo Classification Process" Proposed Rule.
Docket # FDA-2018-N-0236
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February 14, 2019 - CPC's Comments on FDA's Bridging Combination Products Draft Guidance
CPC submitted comments on FDA’s “Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry.” CPC requested that the Agency consider the major overarching comments of concern, as well as line-specific comments.
Docket # FDA-2019-D-5585
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January 22, 2019 - CPC's Comments on FDA's "Prescription Drug-Use-Related Software" Notice
CPC submitted comments in response to FDA's request for comments on the "Prescription Drug-Use-Related Software; Establishment of a Public Docket" issuance.
Docket # FDA-2018-N-3017
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December 3, 2018 - CPC's Request for an Extension to Submit Comments to FDA's Proposed Framework for Regulating Software for Use with Prescription Drugs
CPC requested an extension to submit comments in response to FDA's Proposed Framework for Regulating Software for Use with Prescription Drugs.
Docket # FDA-2018-N-3017
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November 30, 2018 - CPC's Comments on FDA's "Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications" Draft Guidance
CPC submitted comments in response to FDA's "Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications: Draft Guidance for Industry and FDA Staff" Draft Guidance.
Docket # FDA-2018-D-3275
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October 1, 2018 - CPC's Comments on FDA's Notice for a Public Hearing on Devices Proposed for a New Use with an Approved Marketed Drug
CPC submitted comments on FDA's Notice for a Public Hearing on Devices Proposed for a New Use with an Approved Marketed Drug.
Docket # FDA-2017-N-5319
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June 27, 2018 - CPC's Comments on FDA's Proposed Update to the Product Jurisdiction Rule
CPC submitted comments in response to FDA's proposed update to the Product Jurisdiction Rule, 21 CFR part 3.
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June 25, 2018 - CPC's Comments on FDA's "Multiple Function Device Products" Draft Guidance
CPC submitted comments in response to FDA's "Multiple Function Device Products; Draft Guidance for Industry and Food and Drug Administration Staff."
Docket # FDA-D-1339
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June 18, 2018 - CPC's Comments on FDA's "Postmarketing Safety Reporting for Combination Products" Draft Guidance
CPC submitted comments in response to FDA's "Postmarketing Safety Reporting for Combination Products" Draft Guidance.
Docket # FDA-2008-N-0424
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June 18, 2018 - CPC's Comments on FDA's "Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products-Quality Considerations" Draft Guidance
CPC submitted comments in response to FDA's "Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products-Quality Considerations" Draft Guidance.
Docket # FDA-2018-D-1098
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January 10, 2018 - CPC's Comments on "Devices Proposed for a New Use with Approved, Marketed Drug"
CPC submitted comments on FDA's Federal Register Notice entitled "Devices Proposed for a New Use with an Approved, Marketed Drug" and the Public Hearing held on November 16, 2017.
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May 19, 2017 - CPC's Comments on FDA's "Considerations in Demonstrating Interchangeability with a Reference Product" Draft Guidance
CPC submitted comments in response to FDA's "Considerations in Demonstrating Interchangeability with a Reference Product" Draft Guidance.
Docket # FDA-2017-D-0154
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March 20, 2017 - CPC's Comments on FDA's "Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA" Draft Guidance
CPC submitted comments in response to FDA's "Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA" Draft Guidance.
Docket # FDA-2016-D-4412
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October 14, 2016 - CPC's Request for an Extension to Comment on the General and Plastic Surgery Devices Panel Meeting
CPC submitted comments requesting for a 30-day comment extension to submit comments to the "General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting" docket.
Docket # FDA-2016-N-2147
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August 5, 2016 - CPC'S COMMENTS TO THE MEDICINES & HEALTHCARE PRODUCTS REGULATORY AGENCY ON "HUMAN FACTORS AND USABILITY ENGINEERING"
CPC submitted comments in response to the Medicines & Healthcare Products Regulatory Agency's "Human Factors and Usability Engineering Guidance for Medical Devices Including Drug-device Combination Products."
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May 2, 2016 - CPC's Comments on FDA's "Human Factors Studies and Related Clinical Study Considerations" Draft Guidance
CPC submitted comments in response to FDA's "Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development" Draft Guidance.
Docket # FDA-2015-D-4848
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April 28, 2015 - CPC's Comments on FDA's "Current Good Manufacturing Practice Requirements for Combination Products" Draft Guidance
CPC submitted comments in response to FDA's "Current Good Manufacturing Practice Requirements for Combination Products" Draft Guidance.
Docket # 2015-01410
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February 19, 2015 - CPC'S COMMENTS ON NIH'S "CLINICAL TRIALS REGISTRATION AND RESULTS SUBMISSION" PROPOSED RULE
CPC submitted comments in response to NIH's "Clinical Trials Registration and Results Submission" Proposed Rule.
Docket # NIH-2011-0003
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February 13, 2015 - CPC's Request for an Extension to Comment on FDA's Current Good Manufacturing Practice Requirements for Combination Products
CPC submitted a request for a 30-day extension to submit comments in response to FDA's "Current Good Manufacturing Practice Requirements for Combination Products" Draft Guidance.
Docket # 2015-01410
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February 2, 2015 - CPC's Comment on FDA's Draft LDT Framework
CPC submitted comments in response to FDA's Draft Laboratory Developed Test Framework.
Docket # FDA-2011-D-0360
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June 4, 2014 - CPC's Comment on the Report of FDA's Policy Proposals Regarding Premarket Notification Requirements
CPC submitted comments in response to FDA's "Report on FDA's Policy to be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices."
Docket # FDA-2014-N-0237-0001
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December 3, 2013 - CPC's Comments on FDA's "Design Considerations for Devices Intended for Home Use" Draft Guidance
CPC submitted comments in response to FDA's "Design Considerations for Devices Intended for Home Use" Draft Guidance.
Docket # FDA-2012-D-1161-0001
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November 2, 2013 - CPC's Comments on FDA's "Safety Considerations for Product Design to Minimize Medication Errors" Draft Guidance
CPC submitted comments in response to FDA's "Safety Considerations for Product Design to Minimize Medication Errors" Draft Guidance.
Docket # FDA-2012-D-1005
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October 3, 2013 - CPC's Comments on FDA's "Medical Device Reporting for Manufacturers" Draft Guidance
CPC submitted comments in response to FDA's "Medical Device Reporting for Manufacturers" Draft Guidance.
Docket # FDA-2013-D-0743
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July 30, 2013 - CPC's Comments on FDA's "Rheumatoid Arthritis: Developing Drug Products for Treatment" Draft Guidance
CPC submitted comments in response to FDA's "Rheumatoid Arthritis: Developing Drug Products for Treatment" Draft Guidance.
Docket # FDA-2013-D-0571
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July 9, 2013 - CPC's Comments on FDA's "Glass Syringes for Delivering Drug and Biological Products" Draft Guidance
CPC submitted comments in response to FDA's "Glass Syringes for Delivering Drug and Biological Products - Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4" Draft Guidance.
Docket # FDA-2013-D-0362
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July 1, 2013 - CPC's Comments on FDA's "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" Draft Guidance
CPC submitted comments in response to FDA's Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" Draft Guidance.
Docket # FDA-2013-D-0350
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June 12, 2013 - CPC's Comment on FDA's " Use of Certain Symbols in Labeling" Proposed Rule
CPC submitted comments in response to FDA's "Use of Certain Symbols in Labeling" Proposed Rule.
Docket # FDA-2013-N-0125
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May 23, 2013 - CPC's Comment on FDA's "Distinguishing Medical Device Recalls From Product Enhancements" Draft Guidance
CPC submitted comments in response to FDA's "Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements" Draft Guidance.
Docket # FDA-2013-D-0114
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April 19, 2013 - CPC's Comment on FDA's "Submissions for Postapproval Modifications to a Combination Product Approved under a BLA, NDA or PMA" Draft Guidance
CPC submitted comments in response to FDA's "Submissions for Postapproval Modifications to a Combination Product Approved under a BLA, NDA or PMA" Draft Guidance.
Docket # FDA-2012-D-1240
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February 6, 2013 - CPC's Comments on CDRH's FY 2013 Proposed Guidance Development
CPC submitted comments on the Center for Devices and Radiological Health's Website Location for the FY 2013 Proposed Guidance Development Agenda.
Docket # FDA-2012-N-1021
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October 24, 2012 - CPC's Comments on FDA's "Unique Device Identification System" Proposed Rule
CPC submitted comments to FDA's "Unique Device Identification System" Proposed Rule.
Docket # FDA-2011-N-0090 / RIN No. 0910-AG31
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February 27, 2012 - CPC's Comments on FDA's Report on Good Guidance Practices
CPC submitted comments in response to FDA's "Report on Good Guidance Practices: Improving Efficiency and Transparency."
Docket # FDA–2009–N–0247
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December 1, 2011 - CPC's Comments on FDA's "Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency’s Compliance and Enforcement Data"
CPC submitted comments in response to FDA's "Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency’s Compliance and Enforcement Data".
Docket # FDA-2009-N-0247
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November 14, 2011 - CPC's Comments on FDA's "Design Considerations for Pivotal Clinical Investigations for Medical Devices" Draft Guidance
CPC submitted comments in response to FDA's "Design Considerations for Pivotal Clinical Investigations for Medical Devices" Draft Guidance.
Docket # FDA-2011-D-0567
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September 15, 2011 - CPC's Comments on FDA's "Medical Device Innovation Initiative"
CPC submitted comments in response to FDA's "Medical Device Innovation Initiative."
Docket # FDA-2011-N-0063
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September 15, 2011 - CPC's Comments on FDA's "Classification of Products as Drugs and Devices and Additional Product Classification Issues" Draft Guidance
CPC submitted comments in response to FDA's "Classification of Products as Drugs and Devices and Additional Product Classification Issues" Draft Guidance.
Docket # FDA–2011–D–0429
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October 14, 2010 - CPC's Comments on the Reauthorization of the Medical Device User Fee Act
CPC submitted comments to FDA on the “Reauthorization of the Medical Device User Fee Act.”
Docket # FDA-2010-N-0389
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February 5, 2010 - CPC's Comments on FDA's "Current Good Manufacturing Practice Requirements for Combination Products" Proposed Rule
CPC's Comments on FDA's "Current Good Manufacturing Practice Requirements for Combination Products" Proposed Rule.
Docket # FDA–2009–N–0435
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January 29, 2010 - CPC's Comments on FDA's "Postmarketing Safety Reporting for Combination Products" Proposed Rule
CPC submitted comments to FDA's "Postmarket Safety Reporting for Combination Products" Proposed Rule.
Docket # FDA-2008-N-0424
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August 7, 2009 - CPC's Comments to the FDA Transparency Task Force's Request for Comments
CPC submitted comments in response to the FDA's "Food and Drug Administration Transparency Task Force; Notice of Public Meeting; Request for Comments."
Docket # FDA-2009-N-0247
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July 23, 2009 - CPC's Comments on FDA's "Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products" Draft Guidance
CPC submitted comments in response to FDA's "Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products" Draft Guidance.
Docket # FDA-2009-D-0179
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January 2, 2008 - CPC's Comments on FDA's "New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products" Draft Guidance
CPC submitted comments in response to FDA's "New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products" Draft Guidance
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March 5, 2007 - CPC's Comments on FDA's "Supplements and Other Changes to an Approved Application" Public Meeting Notice
CPC submitted comments in response to FDA's "Supplements and Other Changes to an Approved Application" public meeting notice.
Docket # FDA-2006N-0525.
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March 23, 2006 - CPC's Proposals in Response to FDA's "Adverse Event Concept Paper"
CPC submitted comments to FDA's "Adverse Event Concept Paper" and detailed several possible approaches to the reporting of post-market adverse events associated with combination products.
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January 11, 2006 - CPC's Supplemental Comments on Mutually Conforming Labeling
CPC submitted supplemental comments addressing FDA's "Combination Products and Mutually Conforming Labeling" Public Meeting held in 2005.
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November 15, 2005 - CPC's Comments on FDA's "Number of Marketing Applications for a Combination Product" Concept Paper
CPC submitted comments in response to FDA's "Number of Marketing Applications for a Combination Product" Concept Paper.
Docket # FDA-2005N-0098.
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July 8, 2005 - CPC's Comments Following FDA's Public Meeting on Mutually Conforming Labeling
CPC submitted comments as a follow up to the "Combination Products and Mutually Conforming Labeling" public meeting held by FDA.
Docket # FDA-2005N-0098.
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December 3, 2004 - CPC's Comments on FDA's "Current Good Manufacturing Practice for Combination Products" Proposed Rule
CPC submitted comments in response to FDA's "Current Good Manufacturing Practice for Combination Products" Draft Guidance.
Docket # FDA-2004D-0431
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November 24, 2004 - CPC's Comments on FDA's Draft Guidance on the Application User Fees for Combination Products
CPC submitted comments in response to FDA's "Draft Guidance for Industry and FDA Staff: Application User Fees for Combination Product."
Docket # FDA-2004D-0410
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November 24, 2004 - CPC'S COMMENTS ON FDA'S DRAFT GUIDANCE ON USER FEES FOR COMBINATION PRODUCTS
CPC submitted comments in response to FDA's "Draft Guidance for Industry and FDA Staff: Application User Fees for Combination Products."
Docket # FDA-2004D-0410
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August 18, 2004 - CPC's COMMENTS ON FDA'S "PRIMARY MODE OF ACTION OF A COMBINATION PRODUCT" PROPOSED RULE
CPC submitted comments in response to FDA's Proposed Rule and Request for Comment on the "Definition of Primary Mode of Action of a Combination Product."
Docket # FDA-2004N-0194
other advocacy materials
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CPC's Letter to FDA on the "Use of Investigational Digital Medical Devices in Clinical Studies for Medicines"
August 3, 2021 - CPC wrote a letter to FDA following FDA's invitation to provide additional information supporting CPC's requests to FDA's Digital Health Center of Excellence.
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CPC's Letter Congratulating FDA on the "Combination Products Policy Council"
April 20, 2016 - CPC wrote a letter to FDA congratulating FDA on the creation of the “Combination Products Policy Council.”
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CPC's Letter to OMB on FDA's LDT Draft Guidance Document
July 28, 2014 - CPC wrote to the Office of Management and Budget regarding the release of FDA's Draft Laboratory Developed Test Framework.
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CPC's Recommendations on "Improving Patient Care through Better Combination Product Regulation"
May 23, 2014 - CPC submitted its recommendations to the FDA centers on "Improving Patient Care through Better Combination Product Regulation."
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CPC's Letter to FDA on its Upcoming "Draft Guidance for Combination Product Good Manufacturing Practices"
April 2, 2014 - CPC submitted comments to request FDA publish guidance for “Combination Product Good Manufacturing Practices” as soon as possible.
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CPC Injector Systems Working Group - Labeling Q&A
April 7, 2013 - CPC Injector Systems Working Group - Labeling Q&A
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"Points to Consider in Drafting FDA's Co-development Guidance and Other Companion Diagnostic Guidance"
October 19, 2012 - CPC issued "Points to Consider in Drafting FDA's Co-development Guidance and Other Companion Diagnostic Guidance."
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Questions for FDA's Consideration in Finalizing Companion Diagnostic Guidance
June 21, 2012 - CPC's Personalized Medicine Working Group issued "Questions for FDA's Consideration in Finalizing Companion Diagnostic Guidance."
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CPC's Citizen's Petition
June 8, 2012 - CPC submitted a Citizen's Petition to FDA requesting that the FDA take certain actions to improve transparency with regard to combination products, ensure that more Agency records regarding combination products are released on the Agency website, improve the guidance document development processes and procedures, and support greater transparency.
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"Questions Outlining Goals and Top Issues"
June 21, 2012 - CPC's Injector Systems Working Group issued "Questions Outlining Goals and Top Issues" for the June 21, 2012, meeting with FDA.
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CPC's Meeting Request to FDA Regarding "Transparency in Combination Products"
June 20, 2011 - CPC requested a meeting with FDA to address transparency in combination products.
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CPC's Post-Meeting Comments to FDA on "Cross-Labeled Combination Products"
May 1, 2011 - In response to the March 2, 2011, meeting with FDA, CPC submitted comments on cross-labeled combination products.
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CPC's Request for a Meeting with FDA
June 11, 2009 - CPC requested to meet with FDA to continue conversations regarding Good Manufacturing Practices and clinical trial issues related to combination products and post-approval product modification issues.
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CPC's Introduction Letter to Director Nguyen
January 2, 2008 - CPC wrote a letter to congratulate Thinh Nguyen on his appointment as the Director of the Office of Combination Products and wrote to introduce him to CPC. CPC included its "CPC Open Door Forum: Combination Products Guidance Survey and 2008 Policy Agenda" and trade press article with the letter.
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CPC's Follow Up Letter to FDA on "Increasing Transparency in the Application of cGMP Regulations to Combination Products"
July 5, 2006 - CPC wrote to the Office of Combination Products as a follow up to FDA's May 4, 2006, meeting with CPC to continue discussions regarding increasing transparency in the application of cGMP regulations to combination products.
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"Key Areas of Difference Among Regulatory Requirements for Drugs, Devices, and Biologics" Introductory Survey
June 22, 2005 - CPC's Product Selection Issue Working Group issued its "Key Areas of Difference Among Regulatory Requirements for Drugs, Devices, and Biologics" Introductory Survey.