Food and Drug Administration What is the role of HF studies as compared to other types of clinical studies? 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. FDA: “Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products.” • Can be . 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”. 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. ©2019. 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. Rockville, MD 20852. CP Pathways’ principle consultant is Doug Mead – a highly experienced combination products regulatory expert with a diverse background in drugs and devices, including their design and testing, risk analysis, human factors testing, stability testing, and clinical trial real use patient handling assessments.Doug has a network of experienced combination product regulatory … The pipeline of combination products promises unprecedented drug delivery innovations. cross labeled . Representative users test the product to “help eliminate or mitigate any potential use-related hazards”, that may not be evident during the design planning. The broad assumption in the industry is that if a combination or sensitive product … (e.g., new drug product exclusivity, orphan status, or proprietary data protection when two firms are involved). Agency policy regarding postmarket regulation of combination products is outside the scope of this guidance. Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or bi 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. PDG® is a federally registered service mark of Pharmaceutical Development Group, Inc.Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation. 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. Are additional HF studies necessary when the design of the combination product changes? The determination is based on “primary mode of action” (PMOA) of the combination product. Once you know what regulation applies to your product … Regulatory expertise is critical to sponsors including determination of the best pathway for their specific product. 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. The app is used to set reminder alerts for the next injection, with a calendar of all injections that have been scheduled, recorded, or missed. See PDG’s previous articles on FDA’s pre-sub program for how and why this program might benefit the developer of a combination product. The device facilitates more effective treatment or diagnosis of life-threatening or debilitating diseases or conditions. The FDA outlined a new pathway for the expedited approval of medical devices, diagnostics and certain combination products that aim to improve upon the safety of those currently on the market. Search for FDA Guidance Documents, Draft Guidance for Industry and FDA Staff, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, Principles of Premarket Pathways for Combination Products. combination products may be regulated as both a drug and a device • ANVISA determines the designation and regulatory pathway / requirements for combination products on an ad-hoc, case-by-case basis Emerging Regulations in Emerging Markets Examples • Chinese Government Circular # 16 (2009) refers to A combination product invokes an FDA regulatory requirement (21 CFR 300.50) that generally requires the developer to demonstrate that a population exists who would be served by the combination, and that each component of the combination contributes to the clinical effect of the combination product. [4] While OCP is not a review/approval Center for your combination product, they do provide general guidance on which pathway is best for your product and to ensure combination products have general oversight. The US Food and Drug Administration’s (FDA) Office of Combination Products (OCP), established by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), is the regulatory body responsible for covering the regulatory life cycle of combination products, including serving as a focal point for combination product issues, developing guidances, … This key piece of information determines the product’s regulatory pathway, and allows the sponsor to begin the process of submitting its drug device combination product for approval. Implement a plan that gets everyone on board. 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. 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. It is not unusual for sponsors to ask FDA to clarify how HF concepts apply to the development of combination products. You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)). FDA on Prefilled Syringes and Combination Products — What This Means for You ... and melted into the skin and of course I was learning with the innovator as to what kind of things are applicable in a regulatory world, trying to get this thing through the pathway here. 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. 114-255) (“Cures Act”), substantially amended section 503(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 USC 353(g)), the principal section of the FD&C Act expressly addressing combination products. [1] Combination products should not be confused with Fixed-Combination Drugs (FCDs), which are drug-drug combinations. [10] HF studies are generally conducted to evaluate user interfaces. The Office of Combination Products (OCP) was created in 2002 as a result of the Medical Device User Fee and Modernization Act. The 505(b)(1) regulatory pathway is the traditional New Drug Application (NDA). The objective is risk reduction by determining product user issues or related hazards with the products at the early design stage. 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. 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. Section 3038 of the 21st Century Cures Act, enacted in December 2016 (P.L. 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]. The draft guidance was prepared via the support of the International Medical Device Regulators Forum (IMDRF), formerly the Global Harmonization Task Force (GHTF). Because of the substantial amount of research and data that is required, 505(b)(1) NDA … Present Regulatory Pathway for Biologics in US: 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. Note that transdermal patches lead the way. In order to qualify for participation in the Breakthrough Devices Program, a device must meet two key criteria: 1. For combination products, “Intended mode of action by which part” is checked. The .gov means it’s official.Federal government websites often end in .gov or .mil. 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. Thus ultimately, if the sponsor cannot or does not want to decide, the Office of Combinations Products will decide the most important aspect of the combination, either the drug or the device, through the Request for Designation (RFD) process. 2. The earlier described BETACONNECT® will also feature an app to upload data to a smartphone or computer. Definition of combination products - US. A quick search for innovative combination products found a tattoo-like skin patch for diabetes sufferers that can detect glucose levels in its wearer’s sweat and accordingly will deliver a drug as needed. Regulatory Challenges Until now, combination products are more often handled inconsistently different! Human Factors studies ( or aka HF study ) we do so because are! 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