Tag Archives: combination products

FDA Public Hearing on an Innovative Approach to Devices Referencing Drugs

In a new post on the Covington Digital Health blog, we analyze FDA’s proposed approach for device sponsors seeking to market devices referencing drugs (“DRDs”) when the drug sponsor does not wish to collaborate with the sponsor of the device.  FDA will hold a public hearing on November 16, 2017 to discuss DRDs.   To read … Continue Reading

FDA’s Office of Planning Issues Report on Review Process for Combination Products

The pace and process used by FDA for the review of combination products has been the subject of considerable concern by many device companies.  On October 14, 2015, FDA’s Office of Planning issued a report summarizing a study of the intercenter consultation process for the agency’s review of combination products.  The report identifies several challenges … Continue Reading

Bill Introduced to Streamline and Clarify Combination Product Regulatory Process

Sen. Johnny Isakson (R-Ga.) introduced a bi-partisan bill (S. 1767) on July 15, 2015, to help streamline and clarify the FDA regulatory process for combination products.  Co-sponsored by Sens. Robert Casey (D-Pa.) and Pat Roberts (R-Kan.), the “Combination Product Regulatory Fairness Act of 2015” is, according to Roberts, intended to “clarify the regulatory process for … Continue Reading

Court Rejects FDA’s Interpretation of the Statute’s Device Definition as “Erroneous and Unreasonable”

The United States District Court for the District of Columbia, in Prevor v. FDA (Prevor II), rejects for the second time FDA’s “erroneous and unreasonable interpretation” of the definition of “device” under the Federal Food, Drug and Cosmetic Act (FDCA) (op. at 21).  The court has remanded the case to FDA to use a lawful standard … Continue Reading

Regulation of Combination Products: A Hybrid Approach to CGMP and Postmarketing Safety Reporting Requirements

Starting July 22, 2013, as part of their compliance with current good manufacturing practices (“CGMP”), pharmaceutical companies that manufacture combination products containing a device component became subject to device Quality System Regulations (“QSRs”). As we previously discussed, on January 22, 2013, FDA issued a final rule on CGMP requirements for combination products. Under the rule, … Continue Reading
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