and (6) Class III, drug-device combination products (Table 1). Key Point Summary: 1. A combination product’s regulatory pathway generally depends on its primary mode of action (PMOA), recently defined in the 21st Century Cures Act as “the single mode of action of a combination product expected to make the greatest contribution to the overall intended therapeutic effects of the combination product.“3,4 FDA’s Office of Combination Products (OCP) examines the product’s modes of action, determines which is the PMOA, and then uses that to a… or. The earlier described BETACONNECT® will also feature an app to upload data to a smartphone or computer. Take the first step We’ll work with you to assess your product, strategies, team and timelines and develop a package that suits your needs. Pharmaceutical Development Group, Inc. All Rights Reserved. pre-filled syringes, insulin-injector pens. Not surprisingly, “High incidence rates of chronic pain causing diseases, prostate cancer, diabetic retinopathy, cardiovascular diseases, colorectal cancer, asthma, obesity along with rapidly aging global population also form the key drivers for the global drug device combination products market.”[2] However, much of the information herein may be extrapolated to other facets of combination products. Human Cell or Tissue Products The US Code of Federal Regulations Title 21, part Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or bi The .gov means it’s official.Federal government websites often end in .gov or .mil. The 505(b)(1) regulatory pathway is the traditional New Drug Application (NDA). Globally, separate regulatory pathways for innovator products and generic The medical device industry is now capable of using 3D printers to produce everything from prosthetic parts to artificial knees to surgical tools. ©2019. Charles Jaap is Vice-President of Operations and Business Development for PDG®, a global pharmaceutical and medical device consultant with extensive experience in the strategic development of drug products and medical devices. [13] Development of drug/device combination products are usually for convenience of the patient to self-administer, i.e. It is estimated that “approximately 1/3 of all medical products under development today are combination products and total sales could reach $115 billion dollars by 2019”. Not for implementation. [3], As you might imagine, combination products face unique regulatory hurdles regarding review, pathway, post-market regulation, etc. In addition to the use of 3D printers, the advancement of mobile health (mHealth) applications for smart phones and othe… Bill Welch says when developing a combination product, there are many things to be considered – relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation. Note that transdermal patches lead the way. If it’s deemed the drug is the primary mode of action, it will be reviewed by CDER (Center for Drug Evaluation and Research) and likewise, if its deemed the device is the primary mode of action, CDRH (Center for Devices and Radiological Health) will orchestrate the review. Regulatory approval or clearance of a combination product revolves around determination of the primary mode of action (MOA). As you can imagine, this type of submission requires extensive research including both clinical and nonclinical studies to prove the product’s safety and efficacy for the indication being sought. Pharmaceutical Development Programs: Implementation and Oversight, Investigational New Drug Application (IND)/Special Protocol Assessment (SPA), Pre-NDA Meetings and NDA Submissions: 505(b)(1)/505(b)(2), Generic Drugs: 505(j) ANDAs and Potential Diversification, Device Pre-submission Meetings and Reviews, Combination Device and Drug/Biologic Submissions, Supplier/Vendor Selection and Qualification, International Health Authority’s Websites, An Effective Strategy for IND Pharmaceutical Product Development, Regulatory Consulting- the Missing Piece to Your Puzzle, An Introduction to Clinical Trials and Resources for Continued and Intermediate Learning, EMA Drug Post-Marketing Safety Surveillance Changes, US Impact and Compliance Assistance. Food and Drug Administration To reach its ultimate goal of multinational approval, the company needed to develop a regulatory strategy by which the classification of its product as a combination device could be preserved, country-specific clinical trials could be avoided, and the approval process could be expedited. This pathway is used to obtain the approval of a new drug whose active ingredients have not previously been approved. See below for a graph of current and expected North American sales for drug device combination products. There are certain types of combination products where separate marketing applications for the individual constituent parts of the combination product will be reviewed by applicable centers, or there are times a sponsor sees merit in “choosing” this option. In fact, the agency recently released a draft guidance entitled, “Software as a Medical Device (SaMD): Clinical Evaluation.” The draft guidance focuses on establishing the scientific validity, clinical performance, and analytical validity for these types of applications. Implement a plan that gets everyone on board. Should the wrong PMOA be identified, the application may be delayed by the Office of Combination Products (OCP). While not approved as of this writing, innovations such as these are increasing in prevalence with growing consumer expectations related to ease of use, less restrictive living and integration with smart technologies.[15]. However, in 2002, FDA established the Office of Combination Products (OCP) to address, among other issues, ambiguity on how to classify products that cross Center jurisdictions. [1] Combination products should not be confused with Fixed-Combination Drugs (FCDs), which are drug-drug combinations. They caution against restricting combination products to either the premarket approval application or de novo pathways and favor greater discussions on the 510 (k) pathway, including the roles of general and special controls. FDA’s current thinking is that a single application is generally appropriate for a combination product, the guidance notes, with the primary mode of action (PMOA) determining which type of marketing application should be submitted (e.g., a PMA, De Novo, or 510 (k) for a device-led combination product, an NDA or ANDA for a drug-led combination product or a BLA for a … Overcoming Combination Products Regulatory Challenges Until now, combination products are more often handled inconsistently in different jurisdictions as drugs and/or devices. (e.g., new drug product exclusivity, orphan status, or proprietary data protection when two firms are involved). Before sharing sensitive information, make sure you're on a federal government site. Drugs Can be Approved via One of Three Regulatory Pathways New drug products can belong to one of two broad categories: brand new drugs and identical or close copies of previously approved drugs, also called generics. Labeling products as sterile. General themes of these amendments include enhancing clarity, predictability, efficiency, and consistency of premarket regulatory expectations for combination products, including by … The opinions and statements in this paper are solely those of Charles Jaap and Jodi Hutchins and do not necessarily reflect those of PDG©. Device testing includes Human Factors Studies (or aka HF study). We do so because we are so often called upon to address drug delivery devices. cross labeled . Rockville, MD 20852. HF testing is usually done alongside or prior to clinical testing, however not all sponsors are aware of this requirement. Contains non-binding recommendations. Understanding how to bridge your drug to an approved drug and what types of information are appropriate to use is critical to getting your drug approved. FDA is publishing this guidance as part of its efforts to implement Cures Act section 3038 and in keeping with the Agency’s long-standing commitment to transparency, efficiency, and regulatory consistency, to facilitate development of safe and effective combination products. [11], Because HF testing is still relatively new, inquiries to the FDA include:[12]. According to Bayer “all a patient will have to do is prepare the Betaseron® syringes provided in the medication pack and use BETACONNECT® for a more convenient and effective delivery”, that allows patient to select the speed and depth of injections as well. The site is secure. Suttons Creek creates a successful pathway to global regulatory approval and commercialization of your combination products with the following core approaches to our partnerships. The regulatory pathways for drug-device combination products can be confusing – generally, companies decide to pursue a drug pathway or a device pathway based on the primary mode of action. There is not always a clear-cut pathway. [7], FDA has been responsive in accommodating tandem reviews. The device facilitates more effective treatment or diagnosis of life-threatening or debilitating diseases or conditions. Section 3038 of the 21st Century Cures Act, enacted in December 2016 (P.L. General themes of these amendments include enhancing clarity, predictability, efficiency, and consistency of premarket regulatory expectations for combination products, including by ensuring that Agency components and staff coordinate appropriately on premarket review of these products, and that Agency thinking is aligned in conducting these reviews. FDA is assessing industry reaction to a proposed rule on determining a combination product’s primary mode of action – a key concern related to where and how the products are reviewed. It is also broken down by specific products. Definition of combination products - US. For combination products, “Intended mode of action by which part” is checked. Dykeman said that there is a general belief in the field that device pathway is quicker and cheaper, but that isn’t always the case. As more products utilize sophisticated technology, FDA continues to respond in kind. In a world in which we are continuously challenged to operate more efficiently and immersed in rapid technological advances, it should come as no surprise that one of today’s fastest growing medical product segments are combination products. If unable to submit comments online, please mail written comments to: Dockets Management The drug and device industries recognize the demand for more convenience in our fast-paced lives and more advances in our tech savvy world, so they see value in investing money in new product design and development. 5630 Fishers Lane, Rm 1061 2. If a product is a combination of Drug A and Biological B but Mode of action is due to Biological B then as per the assigned category (see above categories), the application will be transferred to either CDER or CBER. [5] It should be noted that the RFD process is currently undergoing changes to include the possibility of a pilot Pre-RFD. Combination products are assigned to Centers with primary jurisdiction for premarket reviews and regulation. For the purpose of this article, we will focus on the drug/device segment. Agency policy regarding postmarket regulation of combination products is outside the scope of this guidance. The 505 (b) (2) development pathway provides far more efficient drug development for follow-on products by allowing reliance on certain external data and information for the NDA. single entity, Co-packaged . [4] The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. In each of the first 3 cases, the products are only appropriate for the 505 (b) (2) pathway if the FDA agrees that the Primary Mode of Action (PMOA) of the entire product is the drug. The Office of Combination Products (OCP) was created in 2002 as a result of the Medical Device User Fee and Modernization Act. For the drug development side, expect consumer study requirements such as label comprehension (understanding the key label message), self-selection (choosing the right product), actual use (using according to labeled directions), or HF (interacting with the product). Office of the Commissioner,Office of Clinical Policy and Programs,Office of Combination Products, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, An official website of the United States government, : The guidance is intended to “assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and AST devices and who seek to coordinate development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter.”[8], Examples of combination products include pre-filled syringes, insulin injector pens, metered dose inhalers, transdermal patches, drug eluting stents, catheters with antimicrobial coatings, infusion pumps, medicated wound treatments and therapeutic orthopedic implants. There has been an explosion of new and innovative medical device products launched in the US and global markets over the last 5 years. Regulatory Pathways of Drug-Device and Device-Drug Combination Products in the EU – Journal 31 NSF: Ann Arbor, MI. The regulatory pathway for combination medical products in the United States is not always clear, and there are no specific FDA regulations that govern approval of combination products. The device represents breakthrough technologies that have no cleared or approved alternatives already available on the US market; offer significant advantages over existing alternative devices; and for which availability is in patients’ best interes… It’s critical to understand the main mode of action of your product as that will determine whether it will be regulated as a medical device or as a medicinal product (drug) in the EU. US Regulatory Pathways for Bone Graft Products The required regulatory pathways by which bone graft products get to market, and the required data to support those pathways are varied. Once you know what regulation applies to your product … PDG® is a federally registered service mark of Pharmaceutical Development Group, Inc.Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation. IMDRF has essentially consolidated forces with a focus on accelerating international medical device regulatory harmonization. “According to BCC Research, sales of the drug-device (segment of combination products alone) reached $21.4 billion in 2013 and $22 billion in 2014. FDA: “Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products.” • Can be . The draft guidance was prepared via the support of the International Medical Device Regulators Forum (IMDRF), formerly the Global Harmonization Task Force (GHTF). This injection history can be emailed directly to the patient or physician, so it is an added feature that benefits the patient and allows oversight by the healthcare provider. Present Regulatory Pathway for Biologics in US: She held her most recent position for 9 years, as QA/RA Director for a worldwide distributor of medical devices. Are additional HF studies necessary when the design of the combination product changes? It is important to have experts on both the drug and device side, not only for the purpose of initial regulatory strategy, but to ensure that through the entire product life cycle, (from design to manufacturing to market), the combination product meets or exceeds quality and regulatory requirements. For the purpose of this article, we will focus on accelerating international medical industry. Aware of this requirement global markets over the last 5 years and expected North American for! Or proprietary data protection when two firms are involved ) 3D printers to produce everything prosthetic! Including determination of the patient to self-administer, i.e delivery innovations regulatory Challenges Until now, combination products ( ). 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