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Article History

Accepted: 18 June 2025

First Online: 5 August 2025

Declarations

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: This study was funded by contract HHS75F40121C00188 with the US FDA. Expert panelist volunteered their time and were not compensated for the participation. The views in this article are those of the authors and not necessarily those of the FDA.

: Cynthia LaCivita was formerly with the Center for Drug Evaluation and Research, US FDA, Silver Spring, MD, USA. She is currently a consultant to Glaxo Smith Kline, United BioSource, and Stallergenes. Anick Berard is the holder of a Canada Research Chair, and a Louis Boivin Family Research Chair on Medications and Pregnancy. The Centers for Disease Control and Prevention receives research funding from the following industry sponsors and a foundation: Amgen, AstraZeneca, GlaxoSmithKline, Janssen Pharmaceuticals, Pfizer, Inc., Regeneron, Hoffman La-Roche-Genentech, Genzyme Sanofi-Aventis, Takeda Pharmaceutical Company Limited, Sanofi, UCB Pharma, USA, Leo Pharma, Sun Pharma Global FZE, Gilead, Novartis, and the Gerber Foundation. Sonia Hernández-Díaz consulted for Roche and Moderna; participated as an investigator in projects funded by Takeda and UCB; and was an advisor for the Antiepileptic and the Antipsychotics Pregnancy Registries, which are funded by multiple companies. Sarah G. Običan has served in the last 2 years as an expert witness working in acetaminophen litigation and polychlorinated biphenyls. Christian Hampp is an employee and shareholder of Regeneron. Caitlin A. Knox is an employee and shareholder of Regeneron and a shareholder of Vertex Pharmaceuticals. Meredith Y. Smith is a shareholder in Thermo Fisher Scientific, Amgen, AbbVie, Abbott, and Eli Lilly. Rachel E. Sobel is an employee and shareholder of Regeneron and a shareholder of Pfizer Inc. Sonja A. Rasmussen serves on scientific advisory committees for several pregnancy registries, including registries for Harmony, Axsome, and Biohaven, recently acquired by Pfizer, Novo Nordisk, and Myovant Sciences. Almut G. Winterstein has received research funding from Merck and has served as a consultant for Merck, Bayer KG, Ipsen, Lykos, Syneos, and Novo Nordisk. Almut G. Winterstein is an Editorial Board member of Drug Safety. Almut G. Winterstein was not involved in the selection of peer reviewers for the manuscript nor in any of the subsequent editorial decisions. Nicole E. Smolinski owns stock through inheritance in Baxter, Cardinal Health, CVS Health, Edwards LifeSciences, and Takeda unrelated to this work. All other authors have no conflicts of interest that are directly relevant to the content of this article.

: This study was approved by the University of Florida Institutional Review Board (IRB202102721). Participants were informed that their participation in the study implied consent.

: All expert panel members provided consent for their participation in this study.

: Not applicable.

: Not applicable.

: Not applicable.

: All authors (1) made substantial contributions to the conception or design of the work, or the acquisition, analysis, or interpretation of data for the work; (2) drafted of the work or reviewed it critically for important intellectual content; (3) gave final approval of the version to be published; and (4) agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.