The results demonstrate that it may be feasible to use NLP tools to extract and map AE terms to MedDRA PTs. However, the NLP tools we tested would need to be modified or reconfigured to lower the error rates to support their use in a regulatory setting. Tools specific for extracting AE terms from drug labels and mapping the terms to MedDRA PTs may need to be developed to support pharmacovigilance. Conducting research using additional NLP systems on a larger, diverse GSL would also be informative.

We ascertained a comprehensive list of postmarket safety outcomes, defined as a safety-related market withdrawal or an update to a safety-related section of product label for 278 new molecular entity drugs (NMEs) with a follow-up period of up to 13 years. At least one safety-related update was added to 195 (70.1%) labels of the drugs studied. Updates occurred as early as 160 days after approval and throughout the follow-up period. The period between the second and eighth postapproval year was the most active, with a slight attenuation thereafter. The times to the first safety outcome were significantly shorter for NMEs approved with a fast-track designation (P = 0.02) or under an accelerated approval using a surrogate endpoint (P = 0.03). Our findings underscore the importance of a robust safety surveillance system throughout a drug's lifecycle and for practitioners and patients to remain updated on drug safety profiles.

Triggered adverse event reporting from patient EHRs is a potentially valuable source of postmarketing safety information, especially for known adverse events. Attention to quality is needed to ensure that the data generated from EHR-triggered ADE reporting systems are relevant to the reported adverse events so that the FDA and others engaged in pharmacovigilance can fully utilize these reports.

Prior research examining postmarketing safety-related regulatory actions have focused on new molecular entity (NME) drugs and has not addressed therapeutic biologics. WHAT QUESTION DID THIS STUDY ADDRESS?  This study examined the association between regulatory and review characteristics and postmarketing safety-related regulatory actions (e.g., withdrawals and updates to safety-related sections of the labels) in new therapeutic biologics (NTBs) and compared the results with these associations in NMEs. WHAT DOES THIS STUDY ADD TO OUR KNOW-LEDGE?  At least one safety-related label update was added to the label of the majority of NTBs. Label updates occurred throughout the follow-up period. Time to the first safety-related regulatory action was shorter for NTBs approved under accelerated approval using a surrogate end point than for those that were not. The occurrence of safety events was higher among NTBs compared with NMEs. NTBs also had shorter time to safety events than NMEs. HOW MIGHT THIS CHANGE CLINICAL PHARMA-COLOGY OR TRANSLATIONAL SCIENCE?  Our analysis demonstrated the need to have a robust safety surveillance system throughout a product's lifecycle with consideration for product type and characteristics.