Combination products present a tremendous opportunity to improve health outcomes, because they leverage multiple disciplines. If we were, for example, to focus on drugs alone with little thought to how they might be delivered, we would be surely missing a chance to enhance safety or effectiveness. Likewise, many devices can be made more effective or safer if paired with a drug.
At the end of 2016, FDA finalized a rule covering Postmarket Safety Reporting for Combination Products that now can be found at 21 C.F.R. Subpart B.[1] A few years later, in July 2019, FDA finalized a guidance ...
Blog Editors
Recent Updates
- Podcast: Navigating the Labyrinth of Private Equity Investments in Health Care – Diagnosing Health Care
- Unpacking Averages: How Old Are Medical Devices on the US Market?
- Three Things That Employer Health Plan Sponsors Should Do When the New MHPAEA Rules Are Published
- CMS Rules Propose Changes Regarding the Medicare Prescription Drug Inflation Rebate Program, Refundable Drugs, Skin Supplements and More; Comments Due September 9
- Recent Supreme Court Decisions and the DSCSA