FDA Guidance: Drug Safety Priorities Fiscal Year 2023 Report

Highlights from the FDA's 2023 Priorities Report

The FDA's Center for Drug Evaluation and Research (CDER) recently released its Drug Safety Priorities 2023 report, detailing a number of advancements and initiatives that safeguard the enhanced safety of both prescription and over-the-counter (OTC) medications, underscoring the FDA's commitment to safety surveillance and risk evaluation whatever the status of the medicinal products.

Within the report, the FDA outlines several key areas of focus: including the surveillance and oversight of marketed medications; the battle against the drug overdose crisis and measures to try to reduce such occurrences; the safeguarding of generic medication quality (GMP), and efforts to manage impurities and contaminants in pharmaceuticals. Most notably, the report highlights the approval of the first OTC naloxone nasal sprays and the continuous efforts to address nitrosamine impurities in a variety of medications.

Due to the broad implications this has on the pharmaceutical industry – affecting drug manufacturers, healthcare providers, and patients – Companies are encouraged to align with these priorities and make stakeholders aware of the FDA's multidisciplinary approach to enhancing drug safety, including the use of Real-World Evidence (RWE), advancements in pharmacovigilance, and the implementation of Risk Evaluation and Mitigation Strategies (REMS).

As best practice, in order to align these practices accordingly, Companies are therefore urged to review the full guidance directly on the FDA's official website and understand the detailed requirements, to ensure compliance with the latest safety standards and contribute to the industry’s goal of enhanced public health protection.

For any questions or assistance for how to best navigate these updates and their implications for your safety operations including the full FDA document, please do not hesitate to contact our team.

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