Small biotech and pharmaceutical companies in clinical development must understand and address safety risks in their compounds to ensure successful regulatory submissions. This requires the effective monitoring and assessment of information available in the scientific literature.
The value of the scientific literature in the detection of possible risks affecting the benefit risk profile of a medicine is recognised by regulators worldwide. When literature monitoring is not performed per regulatory guidance, or left too late, it can lead to missed safety information, submission failures, inspection failures and approval delays causing significant re-work.
To ensure new risks and adverse events are identified as soon as possible, the FDA requires pharmaceutical and biotech companies to monitor the scientific literature for new safety information related to their products from clinical development to post marketing.
When literature monitoring is not performed per regulatory guidance, or left too late, it can lead to missed safety information, submission failures, inspection failures and approval delays causing significant re-work.
In this article we will discuss what are the regulatory requirements mandated by the FDA, the key success factors in establishing compliant literature processes and how biologit seamlessly delivers effective medical literature monitoring platform that meet all regulatory requirements.
FDA Requirements for Literature Monitoring
For drugs and biological products under clinical development, the FDA sets out industry guidance for monitoring and reporting of safety events in the document Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies:
[…] sponsor-investigators are responsible for evaluating all safety information available to them, including data from reports in the scientific literature […]
Further, “Reports in the scientific literature, including unpublished reports of which the sponsor becomes aware” are included in Section V of the guidance, describing the systematic approach for the review of safety information that sponsors should undertake.
The literature monitoring requirement continues in the post marketing stage once products are approved: the FDA sets out regulatory guidance in the document Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines, also mandating strict timelines for reporting safety events:
“Serious, unexpected adverse experiences reported in the scientific literature (or in an unpublished scientific paper) that are known to the applicant must be submitted as 15-day reports” (Section VI)
It is the responsibility of the biotech and pharmaceutical company during all phases of clinical development and post-marketing to ensure that these guidelines are adhered to.
Successful Literature Monitoring Processes
Regulated literature monitoring process expected from sponsors requires careful implementation. Here are key elements to consider, based on FDA’s regulatory guidance:
Search Literature Sources of Global Reach
The FDA guidance states events from the literature should be sourced globally:
“Serious and unexpected adverse experiences from all sources, whether domestic or foreign, must be submitted to the FDA. Possible sources include, for example, scientific literature, postmarketing studies, or commercial marketing experience.” (Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines, Section A)
Carefully Consider What Terms to Search
When searching the literature, sponsors are expected to run broad searches, ensuring that:
“Reports of serious, unexpected adverse experiences described in the scientific literature should be submitted for products that have the same active moiety as a product marketed in the United States. This is true even if the excipient, dosage forms, strengths, routes of administration, and indications vary”
Thus, restrictive search strings may hide important safety events. It is important that search strings are validated and thoroughly justified.
Establish a Repeatable Process with Clear Roles and Responsibilities
At all stages, sponsors are expected to demonstrate compliance with the regulatory guidance for literature monitoring, including:
✔️The process is documented and repeatable, with clear justification, established roles, responsibilities and oversight
✔️Literature searches have been run and assessments carried out consistently and in a timely fashion. All decisions are documented and traceable
✔️Adequate follow up actions have been taken for significant events found in the literature, per regulatory requirements
Starting early ensures adverse events and possible risks that can affect the benefit risk profile of the product are detected and addressed early on in the clinical development process, improving the chances of successful regulatory submissions.
It also demonstrates the company’s commitment to robust safety monitoring processes as products progress from clinical development into postmarketing. A thorough documentation track record helps prevent inspection findings.
FDA Compliant Literature Monitoring with biologit
Ensuring literature monitoring processes are compliant and important safety data is not missed is challenging: the volume of articles being published grows every year, and auditable processes imposes significant “paperwork” burden on safety teams. Manual methods of literature monitoring are resource-intensive, time consuming and carry a risk of an important safety event being missed.
biologit MLM-AI is a complete platform for completing regulated literature monitoring activities effectively and in full compliance. It is designed from the ground up with the needs of safety teams. To learn more get in touch and book a demo today.
biologit Database: Scientific Literature Database for your Regulatory Searches
The biologit Database is a comprehensive scientific literature resource with global and regional reach: updated daily, hosting over 50 million citations and 110,000 journals and fully integrated into the platform. Broad, high quality literature searches are accomplished seamlessly, and results delivered for assessment free of duplicates.
Easy to use SaaS + Fully Configurable Workflows = Productive Teams
From a simple to use web enabled interface, product configuration and assessments are easily completed in a fully auditable environment. A flexible workflow designed for safety monitoring teams supports any literature screening process, and unique AI-powered automation features ensure productive workflows for busy teams, delivering up to 70% efficiency gains compared to manual processes.
Compliance as Standard
biologit MLM-AI Platform is a fully validated and compliant platform built for strict CFR-11 traceability and security requirements. Extensive audit ready features including activity logging, reporting and fine-grained access controls.