Table 1.
Summary of FDA guidances for the mother, fetus and neonate.
| Guidance title | Month, Year | Key contents | Reference [this text] |
|---|---|---|---|
| Guidance for Industry: Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials | April, 2018 | • General scientific and ethical considerations to encourage the inclusion of pregnant women in clinical trials when appropriate. • Evaluation of drugs in clinical trials for conditions to treat medical conditions or acute illnesses that are common in women of reproductive potential. |
(14) |
| Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies | April, 2005 | • Guidance to reviewers for evaluation of human fetal outcome data generated after medical product exposure during pregnancy. • Critical factors to consider when evaluating the effects of drug exposure in human pregnancies, sources of human data on drug exposures, methods for overall assessment of post-marketing human data and labeling. |
(15) |
| Guidance for Industry: General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products | July, 2019 | • Clinical pharmacology considerations specific to the newborn and emphasizes the need for input from a multidisciplinary team when planning for studies enrolling neonates. | (16) |
| Guidance for Industry: Post-approval Pregnancy Safety Studies | May, 2019 | • Recommendations on how to design investigations to assess the outcomes of pregnancies in women exposed to drugs and biological products. | (17) |
| Guidance for Industry: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics | February, 2020 | • Immunomodulating potential of drugs and biologicals, and use of ICH guidances | (18) |
| Guidance for Industry: Safety Testing of Drug Metabolites | March 2020 | • Recommended studies for assessing the safety of metabolites such as: general toxicity studies, genotoxicity studies, carcinogenicity studies, and embryo-fetal development toxicity studies. | (19) |
| Guidance for Industry: Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format | July, 2020 | • Recommendations on complying with the Pregnancy and Lactation Labeling Rule (PLLR) to assist with the content and format requirements for 8.1, 8.2, and 8.3 of the USE IN SPECIFIC POPULATIONS subsections. | (20) |