Emphasizing Literature Surveillance in FDA’s Pharmacovigilance Requirements

Emphasizing Literature Surveillance in FDA’s Pharmacovigilance Requirements

Within the realm of pharmacovigilance, meeting FDA requirements is paramount for ensuring the safe and effective use of healthcare products. Moreover, regulatory bodies often consider this sector the most rigorously regulated pharmaceutical industry segment. Notably, regulators globally emphasize the importance of scientific literature in detecting risks for medicines. Neglecting or delaying literature monitoring as per FDA guidelines can result in missed safety data, submission and inspection failures, and approval delays. Across the globe, regulatory authorities like the FDA and the EMA have established comprehensive requirements to govern pharmacovigilance practices. These include the systematic monitoring and review of medical literature for safety issues. We want to delve deeper into the FDA’s requirements regarding literature monitoring in pharmacovigilance.

FDA Requirements for Effective Pharmacovigilance Literature Monitoring

The FDA, in particular, has outlined essential guidelines and best practices for its staff engaged in postmarketing safety surveillance of marketed drugs and biological products. Their publication, “Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products,” offers valuable insights into effective pharmacovigilance literature monitoring.

Here are key takeaways from this guidance:

1. Vigilant Literature Screening:

  • FDA reviewers are tasked with diligently screening medical literature. They aim to identify emerging safety signals not captured through individual case safety reports (ICSRs) submitted to the FDA.
  • Although the medical literature may contain fewer reports of specific drug-adverse event (AE) combinations, each report typically provides comprehensive details. These details are crucial for safety evaluation.

2. Product-Specific Screening Approach:

  • The extent and frequency of screening FDA AE databases and medical literature vary depending on the product type. Product types are categorized into three groups: A, B, and C.
  • Category A: Reviewers screen newly received ICSRs weekly for products approved within the last three years. This includes new molecular entities (NMEs) and originator biological products. It also covers products without NME designation. These products may have new dosage forms, routes of administration, indications, or patient populations with heightened safety concerns.
  • Category B: Reviewers generally screen newly received ICSRs and medical literature weekly for homeopathic and compounded products.
  • Category C: Reviewers generally screen newly received ICSRs weekly for adverse events in any product in category A beyond three years post-approval, nonprescription drugs, and any product not in category A or B. 
  • Reviewers typically conduct weekly screenings of the medical literature to ensure timely detection of potential safety concerns.

Key Points on Literature Monitoring Obligations: FDA Draft Guidance

In addition to these best practices, FDA draft guidance clarifies the requirements for postmarketing safety reporting for human-marketed drug and biological products.

Here are pertinent points regarding literature monitoring in pharmacovigilance:

1. Reporting Obligations:

  • Pharmaceutical companies must submit reports of serious and unexpected adverse experiences from all sources, including domestic and foreign. They must also report spontaneously reported adverse experiences occurring domestically.
  • Regardless of publication status, serious, unexpected adverse events detailed in scientific literature must be reported to the FDA.
  • Hence, adverse events found in scientific literature and recognized by the applicant should be submitted within 15 days.

2. Submission Process:

  • Applicants can utilize literature search services to identify adverse experiences in scientific literature, ensuring comprehensive surveillance.
  • Reports from scientific literature should be submitted on FDA Form 3500A or a comparable format, with a copy of the article attached.
  • Each identifiable patient experiencing a serious, unexpected adverse experience should have a separate FDA Form completed, with the article attached to only one form.
  • In cases involving multiple products mentioned in an article, the applicant whose product is identified as the suspect drug should submit the report.
  • Foreign language articles should be promptly translated into English for submission to the FDA and the original publication.


In summary, pharmacovigilance plays a crucial role in ensuring the safe use of healthcare products, with literature monitoring being a key component. As outlined in their guidance, regulatory bodies like the FDA emphasize the importance of thorough monitoring. Compliance with reporting obligations and submission processes is essential for effective pharmacovigilance. As evident, literature monitoring in pharmacovigilance is integral to all regulatory recommendations. Additionally, it involves adhering to defined deadlines, including weekly screening. By diligently monitoring scientific literature, stakeholders can swiftly identify emerging safety signals, contributing to enhanced public health outcomes.

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