News Report · Obstetrics Gynecology

FDA Issues Guidance on Postapproval Pregnancy Safety Studies

August 16, 2026

Guidance title

Postapproval Pregnancy Safety Studies

Issuing body

U.S. Food and Drug Administration

Date issued

May 08, 2026

Clinical Perspective

This guidance affects clinicians who care for pregnant patients and other clinicians counseling reproductive-age patients about medication use during pregnancy. The guidance supports generation of postapproval evidence — including pregnancy registries, real-world data studies, and descriptive case reports — that can be used to update drug labeling and inform clinical counseling. How will data from these recommended postapproval approaches be translated into timely labeling updates and practical counseling guidance for clinicians?

Dr. Priya Kapoor, MBBS, MS (Obstetrics & Gynaecology) · Obstetrics and Gynecology

The U.S. Food and Drug Administration issued a final guidance for industry entitled Postapproval Pregnancy Safety Studies on May 08, 2026, with recommendations on methodologies to study safety of drugs and biological products when used during pregnancy ^[4]. The guidance aims to help generate clearer safety information for use during pregnancy by recommending approaches such as pregnancy registries, complementary studies using real-world data, and descriptive studies based on individual case reports ^[4].

Clinical Context

The FDA notes that many pregnant women may benefit from medications to treat ongoing or new health conditions, but often there is limited or no human data available about how products affect pregnancy at the time they are approved ^[4]. Because of this evidence gap, the agency emphasizes the importance of collecting safety information after approval to better understand potential risks to both the pregnant patient and the developing fetus ^[4]. The guidance states that postapproval pregnancy studies often require input from experts in obstetrics, pediatrics, genetics, and statistics to design and interpret results ^[4]. The guidance is intended to inform postmarketing approaches that can generate information suitable for inclusion in drug labeling ^[4].

Key Findings

The FDA issued a FINAL guidance for industry titled Postapproval Pregnancy Safety Studies on May 08, 2026, providing recommended methodologies for studying product safety during pregnancy ^[4].
The guidance describes methods that should be considered in the postapproval setting, including pregnancy registries and complementary studies that evaluate real-world data ^[4].
The guidance also describes descriptive studies that rely on reports from individual cases as part of a broader evidence portfolio for pregnancy safety assessment ^[4].
The stated goal is to generate information that can be included in drug labeling to help healthcare providers and patients make informed decisions about product use during pregnancy ^[4].
The FDA recommends using this guidance in combination with established scientific standards, especially best practices for observational research, and with other relevant FDA guidances on study design, real-world data, pharmacovigilance, and postmarket requirements ^[4].
The guidance document reflects the agency’s current thinking and does not create legally enforceable requirements ^[4].

Safety & Tolerability

Examples of adverse events and safety topics explicitly named in the provided product labeling excerpts include hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) for FASENRA (benralizumab) ^[1].
ICOTYDE (icotrokinra) labeling names infections, tuberculosis risk considerations, and avoidance of live vaccines; most common adverse reactions listed include headache, nausea, cough, fungal infection, and fatigue ^[2].
NEXPLANON (etonogestrel implant) labeling lists complications due to improper insertion and removal including pain, paresthesia, bleeding, hematoma, scarring, infection, and migration to vasculature ^[3].
Adalimumab-aacf labeling includes warnings about serious infections, tuberculosis, and malignancy, and lists infections and injection site reactions among common adverse reactions ^[6].
TOFIDENCE (tocilizumab-bavi) labeling lists risk of serious infections, hepatotoxicity, hypersensitivity reactions including anaphylaxis and serious cutaneous reactions, and laboratory monitoring recommendations ^[7].
COSENTYX (secukinumab) labeling lists infections, hypersensitivity reactions, and recommends evaluation for tuberculosis prior to initiation ^[8].

Study Design

The FDA guidance outlines multiple postapproval study approaches rather than a single mandatory design: pregnancy registries, complementary studies using real-world data, and descriptive case-report–based investigations are described as methods to be considered ^[4]. The guidance recommends that these approaches be used in combination with established scientific standards and best practices for observational research and other relevant FDA guidances on study design, real-world data, pharmacovigilance, and postmarket requirements ^[4]. The guidance emphasizes multidisciplinary input for study planning, including obstetrics, pediatrics, genetics, and statistics, but notes that guidances reflect the agency’s current thinking and are not legally enforceable requirements ^[4]^[5].

FAQ

Q1 What is the drug approved for?

[Information] was not available in the provided source excerpts.

Q2 How does it work?

[Information] was not available in the provided source excerpts.

Q3 What is the dose?

[Information] was not available in the provided source excerpts.

Q4 What are the side effects?

[Information] was not available in the provided source excerpts.

FDA Issues Guidance on Postapproval Pregnancy Safety Studies

Direct Clinical Takeaway & Evidence Summary

FDA Issues Guidance on Postapproval Pregnancy Safety Studies

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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