Regulation of Combination Products in the United States
Jack Wong, Raymond K. Y. Tong in Handbook of Medical Device Regulatory Affairs in Asia, 2018
In the United States, the term “combination product” is a product comprising any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a device, and a biological product (21 CFR 3.2; see 21 USC 353(g)). Types of combination products include physically or chemically combined products (such as drug-eluting stents or syringes marketed prefilled with a drug or biological product); co-packaged products (such as an ampule of a drug packaged together with a delivery device, first aid kits that include bandages and drugs to treat wounds and other injuries, or surgical kits that include devices and drugs that might be used for a particular type of surgical procedure); and certain separately marketed but “cross-labeled” products (such as a laser and a light-activated drug that are marketed separately from one another but labeled specifically for use with one another). See 21 CFR 3.2(e).
Nanotechnology: Regulatory Perspective for Drug Development in Cancer Therapeutics
Mansoor M. Amiji in Nanotechnology for Cancer Therapy, 2006
Because combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA centers, they also raise challenging regulatory, policy, and review management issues. A number of criticisms have been raised regarding the FDA’s regulation of combination products. These include concerns about the consistency, predictability, and transparency of the assignment process; issues related to the management of the review process when two (or more) FDA centers have review responsibilities for a combination product; lack of clarity about the postmarket regulatory controls applicable to combination products; and lack of clarity regarding certain Agency policies, such as when applications to more than one agency center are needed.
Regulatory Issues in Drug Delivery to the Eye
Glenn J. Jaffe, Paul Ashton, P. Andrew Pearson in Intraocular Drug Delivery, 2006
A combination product can be a device that contains a drug product or a drug product that relies on a device for administration. The FDA will make a determination if the product will be regulated by the Center for Devices and Radiological Health (CDRH) or the Center for Drug Evaluation and Research (CDER). The FDA makes this determination based on the properties of the product (17–19). A drug that is delivered to the retina via an implantable device would be regulated as a drug since the intended outcome of therapy is dependent on the pharmacologic action of the drug. The implant is used solely to deliver the drug to the back of the eye.
The road to market implantable drug delivery systems: a review on US FDA’s regulatory framework and quality control requirements
Published in Pharmaceutical Development and Technology, 2018
Sana Al-Jawadi, Pier Capasso, Manisha Sharma
Accordingly, the need for clearer identification and affirmation of the developmental route required for a new implantable drug delivery system are some of the key aspects for future improvement of the regulatory framework currently in place for such products (Amor 2015). Though the FDA does offer and encourage early consultation to assist in providing early class determination for products in development, as well as offering guidance in setting developmental milestones to assist in designing and developing the appropriate studies for ascertaining safety and efficacy, few guidance procedures are only available (FDA 2016c). Furthermore, the complexities of addressing issues for the product as a whole presents additional challenges to developers, particularly if the either components are new or unregulated (FDA 2016c, 2017c). The cost and resources involved in developing a component in addition to the whole combination product may be excessive. This unfortunately creates an infrastructure that greatly encourages combining regulated components as the system does not provide clear guidance to develop a combination product and one of its constituents simultaneously. Another frontier for FDA thus lies with developing clearer guidance for combination products that include a novel constituent (O'Shea 2014).
Insights into human factor studies conducted for US FDA-approved biological combination products
Published in Expert Opinion on Drug Delivery, 2019
Ronak Patel, Miten Mehta, Parag Pipalava, Meghana Dahiya, Inderjeet Singh, Vinu Jose
Recent advances in technology have led to increasing number of products being developed as a combination product (drug and device, biological product, and device). For patients with chronic diseases, combination products offer several advantages, such as self-injection, improved patient convenience and compliance, and lowering healthcare cost associated with physician’s visits and administration charges. At present, pre-filled syringe (PFS), pre-filled pen, and autoinjector are the most commonly available devices for several drug products, especially biological products [1–3].
Role of nanotechnology in the prolonged release of drugs by the subcutaneous route
Published in Expert Opinion on Drug Delivery, 2023
The Federal Food, Drug, Cosmetic Act and Public Health Service Act regulate pharmaceuticals at the FDA. The first covers the regulation of all chemical compounds and devices, and the second covers biological derivatives. Nanosystems, as they do not fully fit into one of these two categories, are categorized as complex formulations with multiple components; therefore, they are combined products. A combination product is an association between a drug and device, device and biological, drug and biological, or even the three.
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