News

August 28, 2019

CPC Comments on 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Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format: Draft Guidance for Industry”

On August 28, 2019, the CPC submitted comments on 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Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format: Draft Guidance for Industry.” While the CPC appreciates the value of this Draft Guidance in providing FDA’s expectations for IFUs to ensure a more consistent review experience, especially for combination products, the CPC has some concerns and suggestions for improvement. Specifically, we recommend that FDA revise the document to: (1) clarify that the final layout and content of an IFU should be based on outcomes of the human factors (“HF”) process and the expertise of instructional design professionals, and that the content and layout proposed within the Draft Guidance are suggested, but not required; (2) provide clearer guidance on the criteria by which a manufacturer decides whether a product requires an IFU; (3) clarify the scope of the Draft Guidance; and (4) provide additional guidance on how and when IFUs are to be submitted for review.

August 26, 2019

CPC Comments on FDA’s “New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication”

On August 26, 2019, the CPC filed a comment letter regarding FDA’s “New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication,” and specifically, the proposed new integrated review template. While the CPC supports the integrated review template and acknowledges the value of implementing a system that effectively communicates the basis for new drug approvals, CPC is concerned that the proposed integrated review template will lack the level of detail currently provided in the discipline-specific review memos.  CPC strongly requests that, as FDA implements the integrated review document, the discipline-specific review memos remain publicly available to ensure full transparency and understanding of the Agency’s current thinking with respect to combination product requirements.

May 31, 2019

CPC Comments on FDA’s “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback”

On May 31, 2019, CPC filed comments on FDA’s “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback” (“Discussion Paper”). While the CPC believes FDA’s proposed approach on AI/ML is well-constructed, we asked that the Agency consider certain general comments/requests, including that FDA: (i) compose any future discussion papers on AI/ML to consider broader and more pressing issues around AI/ML, including use of AI/ML in interpreting real-world and well-controlled clinical data as well as human understanding and interpretation of AI/ML algorithms; (ii) address the critical question of when a continuously adaptive AI/ML may require a premarket submission, as the proposed framework currently addresses only incremental learning algorithms with gating mechanisms for updates; and (iii) provide clarity on what least burdensome AI/ML submissions from industry look like throughout the product lifecycle. We also provided specific responses to the questions posed by FDA in the Discussion Paper.

May 6, 2019

CPC Submits Comments on FDA’s Premarket Pathways Draft Guidance

On May 6, 2019, CPC provided comments on FDA’s “Principles of Premarket Pathways for Combination Products: Draft Guidance for Industry and FDA Staff.” Although the document helps clarify certain FDA expectations, among other feedback, the CPC recommends that FDA: (i) include additional guidance on considerations for cross-labeled combination products with respect to the one v. multiple application determination; (ii) provide additional guidance on when the data and information needed to obtain marketing authorization for a non-lead constituent part either differs or does not differ from that needed as a stand-alone product; and (iii) provide further guidance on how to effectively utilize prior FDA findings of safety or effectiveness or substantial equivalence of an approved or cleared constituent part.

April 9, 2019

CPC Comments on CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Draft Guidance

On April 9, 2019, CPC provided comments on FDA’s proposed CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality. Our comment letter asks FDA to provide a number of clarifications in the Draft Guidance, including: (1) confirming that the scope of the Draft Guidance includes combination products under CDER jurisdiction; (2) clarifying how the proposed CDER Program will align with the CDRH Standards and Conformity Assessment Program for the device constituent(s) of combination products under CDER jurisdiction; (3) clarifying how the informal nature of the CDER Program will ensure predictability and consistency across CDER for the same device constituent and the same standard; and (4) clarifying the type of standards that are expected to be a part of the CDER Program.

March 7, 2019

CPC Provides Comments on FDA’s Proposed Rule for the Medical Device De Novo Classification Process

On March 7, 2019, CPC provided feedback on the proposed rule for the Medical Device De Novo Classification Process. As part of this feedback, CPC notes that it concurs with and supports the applicability of the De Novo process to the device constituent of what are commonly referred to as “cross-labeled” combination products, and asks FDA to consider including “co-packaged” combination products (per 21 C.F.R. § 3.2(e)(2)) that are designated as device mode of action in the De Novo process, as such products would also benefit from the application of least burdensome provisions and potentially classification as Class II devices.

January 22, 2019

CPC Comments on FDA’s Proposed Framework for Regulating Software Intended for Use with Prescription Drugs

On January 22, 2019, CPC provided input on the Federal Register Notice entitled “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments.” While the CPC applauds the Agency’s efforts to develop a proposed framework to address the ever-increasing array of digital innovations associated with pharmaceuticals, the CPC has certain concerns regarding the proposed framework, as discussed within the comment letter.

December 3, 2018

CPC Requests Extra 30 Days to Comment on FDA’s Proposed Framework for Regulating Software Intended for Use with Prescription Drugs

The CPC has been intently focused on the issue of how FDA will regulate software developed for use with drugs and believes additional time (until February 21, 2019) for commenting on FDA’s proposed framework is warranted given:

•  the timing of the commenting period (which falls across the holidays);
•  the length and complexity of the proposal;
•  the limited window for potential discussion with FDA before submitting comments; and
•  the fact that an extension is unlikely to harm the interested parties.

November 30, 2018

CPC Provides Comments on 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”

While CPC supports certain recommendations detailed in the Draft Guidance, we also recommend several revisions.  For example, we ask that FDA revise the document to provide clear guidance and delineation as to which HF tools are applicable to which types of submissions/situations. We also ask that FDA only request that sponsors provide representative samples of their own product for certain submission types and remove the request for samples of competitors’ reference products.


January 19, 2018

CPC Conducts Survey on FDA’s Final Rule on Postmarket Safety Reporting for Combination Products

The Combination Products Coalition (“CPC”) is conducting a brief survey to assess industry readiness for implementation of FDA’s Final Rule on Postmarketing Safety Reporting for Combination Products (available here). We hope to use your responses to help advise FDA on reasonable expectations for how long it will take companies to come into compliance with the Final Rule as well as provide insight about potential hurdles, recognizing that FDA guidance on the Final Rule is still forthcoming.  All of your responses will be kept anonymous.

We would like to have one response per applicable survey (combination product, companion diagnostic, or both) from each company or independent business unit so that information is not duplicated.  Therefore, we ask that you designate an individual at your company/unit to collect information from, and complete a single survey for, the company/unit.  We estimate that it will take approximately 10 minutes to complete the survey.

Take the survey here: https://www.surveymonkey.com/r/MGGXK9D

Please Complete the Survey No Later Than February 2, 2018.

We thank you in advance for your participation. If you have any questions, please feel free to contact Priya Kaulich at PKaulich@ebglaw.com or 312.499.1433.

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