FDA Releases Proposed Guidance On Combination Products

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Updated July 5, 2024:

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FDA - Combination Products Guidance Documents

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This Federal Register notice announces the FDA release of a proposed rule on combination products, Current Good Manufacturing Practice Requirements for Combination Products (pdf). According to the FDA Law Blog post, FDA Issues Proposed Rule on cGMPs for Combination Products:

The proposed rule does not independently establish new requirements, rather, it clarifies which set of existing cGMP regulatory requirements apply when drugs, devices, and biological products are combined to create a combination product.

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FDA Draft Guidance on Injectors

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To address the increasing popularity of drug-injector systems, the FDA (Food and Drug Administration) released a draft guidance, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products. 

The draft guidance applies to, but is not limited to, jet, pen, needle-free, and mechanically operated injectors as well as piston syringes and injectors with computerized or electronic elements. Injectors are categorized into three groups: those intended for use with a wide range of currently marketed drugs or biological products, those intended for use with a specific class or product line, and those intended for use with a specific product. 

 The FDA is providing this draft guidance document to assist industry in developing technical and scientific information to support a marketing application for a pen, jet, or related injector device intended for use with drugs and biological products. The marketing application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA) application for the injector alone. 

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New FDA Guidance - New Contrast Imaging Indication Considerations

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The FDA has just released this new guidance document, "Guidance for Industry: New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (pdf)." 

To get quickly up to speed on the gist of the guidance, read this commentary posted on the FDA Law Blog, "FDA Issues Contrast Imaging Draft Guidance; Implements Umbrella Approach to Imaging Device Labeling." 

In a nutshell, here's what the guidance covers . . . The guidance describes a process that allows either the imaging drug or imaging device developers to seek approval of medical imaging contrast indications using an already marketed imaging drug or biological product, including radiopharmaceuticals. 

 1. Device developers should generally submit a marketing application to add a new indication for using an already approved imaging drug under the circumstances described in this guidance. 1a. The data to establish these indications in a device application should include information developed in accordance with FDA existing guidance on Developing Medical Imaging Drug and Biological Products. 1b. For most types of indications as described in this guidance, when submitted to request marketing under a device application, the submission should be a Premarket Application (PMA). 

 2. Drug or biological product application holders of the already marketed imaging drug or biological product should generally submit an efficacy or labeling supplement, as appropriate, to add labeling for the new indication initially developed under a device application. 

 3. Device application holders may continue their current practice to request approval or clearance of labeling revisions for any new indications that may be initially approved in a supplement to the NDA for the imaging drug. 

 4. FDA expects to establish an internal intercenter imaging process to review and evaluate indications to ensure consistency in the development and review of clinical trials to establish the contrast indications that may be in either the drug or device labeling. 

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