Are Your Combination Products Ready for the FDA’s Regulations, Effective July 2020?

In recent years, we have witnessed an increase in patients’ expectations for more innovative approaches from pharmaceutical companies in developing medical products that are easy to use, deliver the correct dose of a drug to a precise part of the body, and do so according to a set schedule.

Combination products (medical products combining devices, drugs, and/or biologics) play an important part in meeting these patient expectations, but patient safety remains paramount in this changing environment. Application holders for combination products must understand their responsibilities and work to meet safety requirements from the US Food and Drug Administration (FDA).

The FDA released its final guidance for industry and FDA staff on July 22, 2019, to further clarify how application holders can comply with the 2016 Postmarketing Safety Reporting requirements (PMSR) for combination products, as codified in 21 CFR Part 4, Subpart B.

By July 2020, it is expected that combination products application holders using the FDA Adverse Event Reporting System (FAERS) and Electronic Medical Device Reporting System (eMDR) will comply with the Final Rule on PMSR.

By the end of January 2021, the Vaccine Adverse Event Reporting System (VAERS) will be ready to receive individual case safety reports (ICSRs) according to Final Rule on PMSR.

Is your company ready to meet these requirements for your combination products? Are you sure?

Our pharmacovigilance team can provide full-service pharmacovigilance to ensure your company meets the FDA requirements. If you have questions or need more information, contact us: 877-477-0977 or

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