News

August 3, 2021

CPC Letter to FDA Regarding the Use of Investigational Digital Medical Devices in Clinical Studies for Medicines

On August 3, 2021, the CPC submitted a letter to FDA proposing that the agency adopt a risk-based policy that would relax medical device Current Good Manufacturing Practice expectations for certain low-risk medical device digital technologies deployed into Investigational New Drug Application studies. CPC detailed the applicability of its proposal, risk criteria and categories, and information required to be disclosed under the proposal. CPC emphasized that “[b]y establishing a risk-based policy allowing study sponsors to apply state-of-the-art software development and validation approaches, [FDA] will greatly improve the pace at which pharmaceutical and combination products sponsors can deploy these technologies to the benefit of patients and investigators.”

July 19, 2021

CPC Comments on FDA’s “ICH Q12: Implementation Considerations for FDA-Regulated Products” Draft Guidance for Industry

On July 19, 2021, the CPC filed a comment letter regarding FDA’s “ICH Q12: Implementation Considerations for FDA-Regulated Products” Draft Guidance. The CPC appreciates FDA’s efforts to incorporate many of the CPC’s suggestions regarding the application of ICH Q12 to combination products into FDA’s Draft Guidance. Further, CPC believes that the Draft Guidance represents a significant step forward toward enabling the combination product industry to implement ICH Q12 tools.  The comments also seek additional clarity regarding the term “indirect contact” as used in the Draft Guidance.

July 12, 2021

CPC Comments on Health Canada’s Drug-Device Combination Products (DDCPs) Draft for Consultation Issue Identification Paper

On July 12, 2021, the CPC filed a comment letter regarding Health Canada’s “Drug-Device Combination Products (DDCPs) Draft for Consultation Issue Identification Paper.” The CPC appreciates Health Canada’s efforts to address the uniquely complex and challenging oversight required for drug-device combination products. CPC believes that global harmonization of certain standards for DDCPs across jurisdictions and streamlined approaches to minimize regulatory burdens would expedite access to innovative treatments for patients.  Among other specific recommendations, CPC encourages Health Canada to issue clear guidance documents regarding these important issues.

April 6, 2021

CPC Comments on FDA’s Draft Guidance “Human Gene Therapy for Neurodegenerative Diseases”

On April 6, 2021, the CPC filed a comment letter on FDA’s draft guidance “Human Gene Therapy for Neurodegenerative Diseases.” The CPC appreciates FDA’s efforts to provide additional guidance for delivery devices used with human gene therapy products, but offers certain recommendations regarding the delivery device-related expectations described in the draft guidance.  Overall, these comments suggest that FDA pursue a more flexible approach with regard to sponsors’ use of delivery devices.

December 14, 2020

CPC Submits Comments on FDA’s Draft Guidance “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin”

On December 14, 2020, the CPC submitted comments on FDA’s Draft Guidance “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin” (the “Draft Guidance”). The CPC generally agrees with the concepts proposed in the Draft Guidance, and appreciates FDA’s recognition of the low risk posed by various common device materials that contact intact skin, but has identified areas of the document that would benefit from additional clarity. The CPC also recommends inclusion of combination products within the scope of the Draft Guidance.

September 28, 2020

CPC Offers Comments on FDA’s Integrated Review Documentation Template

On September 28, 2020, CPC submitted comments on FDA’s “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.” While CPC supports the integrated review template and acknowledges the value of implementing a system that effectively communicates the basis for new drug approvals, we are concerned that the proposed integrated review template will lack the level of detail currently provided in the discipline-specific review memos, which our members regularly reference. As such, we strongly recommend 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.

September 11, 2020

CPC Pens Proposed Considerations for FDA Guidance on Cross-Labeled Combination Products and “Combined Use”

The CPC has provided this document to inform potential guidance on cross-labeled combination products and “combined use,” noting that this has not been agreed to by FDA, but we hope can facilitate future discussions on the topic. Contents include background on the topic, impact on industry, request for guidance and considerations (defining cross-labeled combination products, regulatory requirements for such products, and defining “combined use”), and examples of cross-labeling and combined use.

June 22, 2020

CPC Provides Comments on FDA’s Draft Guidance for Demonstrating Reliability of Emergency-Use Injectors

On June 22, 2020, the CPC filed comments on FDA’s “Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and FDA Staff.” While we appreciate FDA’s efforts in providing needed guidance on this topic, we believe many of the recommendations in the Draft Guidance will create inherent regulatory uncertainty (if requirements are strictly imposed in FDA NDA/BLA review correspondence late in development), and some recommendations do not appear to be practical. The comment letter offers 11 major comments, including requests for FDA to resolve uncertainty around (among other areas) the parameters to which the 99.999% reliability specification applies, the point at which the specified reliability must be met, and the devices that fall within the scope of the Draft Guidance.

May 18, 2020

CPC Comments on FDA’s Draft Guidance on Flow Restrictors for Oral Liquid Drug Products

On May 18, 2020, CPC filed comments on FDA’s “Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry.” In addition to certain specific comments, CPC asked that FDA further clarify the designation of restricted delivery systems, including whether they are considered as medical devices, as part of the drug container closure system/package or combination products. In addition, we noted that the Draft Guidance should lay out considerations and recommendations for use of restricted delivery systems, but should not outline requirements for their use. As such, we asked that the Draft Guidance be updated to provide considerations for manufacturers to address during their risk-based development activities and revise the sections which appear to be defining requirements.

February 24, 2020

CPC Provides Comments on FDA’s Proposed Approach for Sponsors Requesting Agency Feedback for Combination Products

On February 24, 2020, CPC submitted comments on FDA’s draft guidance “Requesting Food and Drug Administration Feedback on Combination Products.” CPC appreciates 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. However, CPC has identified the following overall concerns and suggestions:

•  FDA should revise the Draft Guidance to describe the parameters for CPAM interactions, including when a CPAM would be appropriate over an application-based mechanism along with examples.
•  CPC recommends that FDA include opportunities for iteration of proposals, which are linked back to the earlier discussion to allow for sponsors to receive FDA feedback, revise proposals and discuss with FDA until ‘agreement is reached,’ which is common to other types of formal meetings.
•  CPC recommends that FDA provide more detailed timelines for the CPAM submissions and responses.
•  The guidance should focus on the new or distinct information related to combination product meetings through the application-based and CPAM mechanisms and remove the content that is duplicated from other guidance.
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