Breaking Down FDA’s E21 Draft Guidance: Including Pregnant and Breastfeeding Women in Clinical Trials with Regina Atim

The FDA Group’s Nick Capman speaks with Regina Atim, PharmD, pharmacist, maternal and perinatal health advocate, and founder of Clinicians Touch Healthcare Solutions. Regina brings deep expertise at the intersection of clinical practice, regulatory strategy, and maternal health innovation—including work on technologies to detect pregnancy-acquired cardiovascular disease.Their conversation explores FDA/ICH’s new E21 draft guidance, Inclusion of Pregnant and Breastfeeding Women in Clinical Trials. Regina explains why pregnant and breastfeeding women have historically been excluded from research, how that has left clinicians and patients with insufficient evidence, and why E21 represents a cultural and scientific shift toward safe, risk-based inclusion.Read the draft guidance here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e21-inclusion-pregnant-and-breastfeeding-women-clinical-trialsRegina shares practical insights on:How physiologic changes in pregnancy alter drug absorption, distribution, metabolism, and elimination.The dangers of underdosing, overdosing, or avoiding treatment altogether in the absence of trial data.Why clinicians should avoid inappropriate substitutions (e.g., some NSAIDs) and instead rely on evidence-based dosing.How E21 encourages continued monitoring of participants who become pregnant during a trial rather than automatic withdrawal.The stepwise approach to lactation studies—starting with breast milk concentration, then estimating infant dose, and eventually assessing infant exposure and safety.The role of PK/PD modeling, nonclinical data, and real-world evidence in bridging evidence gaps.How sponsors can engage FDA early to align on inclusion triggers and maternal–fetal expertise.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/