Best Practices for Postmarket Drug Safety Surveillance: FDA Seeks Comments

Regulatory NewsRegulatory News | 06 November 2019 |  By 

The US Food and Drug Administration (FDA) on Wednesday released for public comment a draft version of best practices in drug and biologic postmarket safety surveillance.

The best practices document is the result of the 21st Century Cures Act, which eliminated FDA’s periodic summary analyses of adverse drug reaction reports, which FDA has called “largely redundant,” and required that FDA make publicly available on its website best practices for drug safety surveillance activities.

“The drug safety surveillance principles and best practices detailed in this document build upon lessons learned in preparing and publicly posting the summary analyses of adverse drug reaction reports,” FDA says in the draft document.

The 36-page draft offers an overview of safety surveillance for different types of products, such as generic drugs, over-the-counter (OTC) drugs, orphan drugs and combination products, as well as discussions of specific patient populations (pregnant, pediatric and geriatric), safety signal identification, evaluation and documentation, and actions the agency can take.

The extent and frequency of screening the FDA adverse event databases and the medical literature varies with the product type, the document says, noting that products are grouped into three categories:
  • Category A) On a weekly basis, reviewers screen newly received individual case safety reports (ICSRs) for products in the first three years following approval, including new molecular entities, biologics, biosimilars and products with new dosage forms;
  • Category B) Reviewers generally screen on a weekly basis newly received ICSRs and the medical literature for homeopathic and compounded products; and
  • Category C) For newly received ICSRs that report AEs of interest for drugs beyond 3 years postapproval, OTC products, and any product not in category A or B.
As far as actions FDA can take when a safety signal is spotted, the document discusses product labeling changes, safety communications, postmarket studies and trials, enhanced pharmacovigilance, the posting of potential safety signals online and Risk Evaluation and Mitigation Strategies.

“FDA aims to support and further develop new data systems, new surveillance infrastructure, and new methodological tools to complement its existing resources,” the agency says.

Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff: Draft


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