A review of pregnancy and lactation postmarketing studies required by the <scp>FDA</scp>

Krastein, Jason; Şahin, Leyla; Yao, Lynne

doi:10.1002/pds.5572

Cited by 5 publications

(3 citation statements)

References 6 publications

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“…1,3 Postapproval clinical trials and studies have been evaluated from various perspectives. Examples include PMRs established under other FDA regulatory authorities [4][5][6][7][8][9][10][11] (e.g., accelerated approval), assessments of both PMRs and postmarketing commitments (PMCs), 7,9,10,[12][13][14] those required for specific therapeutic areas of interest 9,11,13,[15][16][17] (e.g., cancer drugs), or required by other regulatory agencies (e.g., European Medicines Agency). 15,18,19 The purpose of this study was to undertake an assessment of PMRs that applicants are required to conduct to address a serious safety concern (hereafter referred to as FDAAA 20 PMRs).…”

Section: Introduction 1| Backgroundmentioning

confidence: 99%

A descriptive analysis of postmarketing requirement studies and clinical trials

Choi,

Etchey,

Billings

et al. 2023

Pharmacoepidemiology and Drug

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PurposeUnder the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA has the authority to require applicants to conduct postmarketing studies or clinical trials. These postmarketing requirements (PMRs) provide additional data on the safety of the drug product. The purpose of the study was to conduct a descriptive analysis of FDAAA PMRs and the resulting regulatory actions.MethodsThis study evaluated FDAAA PMRs established between 2013 and 2019. We used the Medical Dictionary for Regulatory Activities (MedDRA) to map preferred terms (PTs) for serious risks associated with the PMRs. Relevant documents available in the FDA's document archiving, reporting, and regulatory tracking system (DARRTS), including but not limited to internal letters and reviews, documents submitted by applicants, and publicly available data sources were assessed for data collection of study elements.ResultsOf the 1079 new FDAAA PMRs established between January 01, 2013, and December 31, 2019, 82% (n = 884) were associated with new drug applications (NDAs) and 18% (n = 195) with biologic license applications (BLAs). Most PMRs were established at the time of drug approval (73%, n = 789) compared to post‐approval (27%, n = 290). The majority of PMRs had an open status (59%, n = 639) and 41% (n = 440) were closed. The median time from the PMR establishment date to submission of the results to the FDA was 690 days (interquartile range [IQR]: 748 days) for 167 completed clinical trials and 483 days (IQR: 603 days) for 241 completed studies. Approximately 53% (180/339) of fulfilled FDAAA PMRs resulted in labeling changes.ConclusionsFDAAA PMRs are useful in informing postmarket safety of drugs. Most FDAAA PMRs were established at the time of drug approval, reflecting safety signals identified during the review of the marketing application, and over half of fulfilled FDAAA PMRs resulted in regulatory action.

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Section: Introduction 1| Backgroundmentioning

confidence: 99%

A descriptive analysis of postmarketing requirement studies and clinical trials

Choi,

Etchey,

Billings

et al. 2023

Pharmacoepidemiology and Drug

View full text Add to dashboard Cite

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“…Currently, health authorities expect market authorization holders to utilize pregnancy registries 11 and/or analyses of mother‐infant linked real‐world data 12 for generating additional evidence on benefits and risks of medicines used during pregnancy 8,9 to fulfill post‐authorization requirements. Since 2016, there has been an increase in the issuance of two safety post‐marketing requirements (PMRs) in the United States, often for both a pregnancy registry and a pregnancy retrospective cohort study 13 …”

Section: Introductionmentioning

confidence: 99%

“…Since 2016, there has been an increase in the issuance of two safety post-marketing requirements (PMRs) in the United States, often for both a pregnancy registry and a pregnancy retrospective cohort study. 13 We conducted a landscape review of real-world data sources specific to pregnancy and breastfeeding populations, capturing maternal medication exposures linked to pregnancy and infant outcomes. The aim of this work was to highlight the current state and opportunities to drive solutions for efficient evidence generation using robust data sources that fully characterize the benefit-risk profile of medications used during pregnancy and breastfeeding, including assessing whether a data source has been or could be used for fit-for-purpose research to meet requirements of health authorities.…”

Section: Introductionmentioning

confidence: 99%

Landscape review of global real‐world data sources for studying medication use in pregnancy and lactation that support regulatory decision making

Davis,

Yost,

Brauneis

et al. 2023

Pharmacoepidemiology and Drug

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PurposeMost pregnant people take at least one medication during gestation or while breastfeeding, however data are lacking on the safety of medication use in these populations. We conducted a landscape review of real‐world data sources specific to medication use in pregnancy and breastfeeding populations that have met, or have potential to meet, health authorities' requirements for post‐authorization safety studies.MethodsA 2‐phase approach identified data sources from literature, publicly available registers of non‐interventional post‐authorization studies of pregnant women, existing database inventories, and emerging data sources known to the authors.ResultsRequired key attributes were assessed according to current regulatory guidance, resulting in selection of 49 suitable data sources. All global regions were represented, with North America (37%) and Europe (33%) most common; 12% of the data sources included pregnancy information from low‐to middle‐income countries. Administrative healthcare claims (25%) and electronic healthcare records (21%) comprised the largest types of data sources. Across data sources, 53% were managed by national or regional governments, 27% by industry, and 20% by academic institutions. Maternal age, diagnoses, prenatal care, and reproductive history were available in most, whereas fewer included demographic data (e.g., race/ethnicity). Breastfeeding data were collected in 37% of the final data sources.ConclusionWe conducted a systematic approach to data source evaluation of pregnancy and breastfeeding to be used as a resource for investigators to consider when designing pregnancy‐related research studies to satisfy regulatory requirements.

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