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Scientific, ethical, and legal considerations for the inclusion of pregnant people in clinical trials.
Sewell, Catherine A; Sheehan, Sarah M; Gill, Mira S; Henry, Leslie Meltzer; Bucci-Rechtweg, Christina; Gyamfi-Bannerman, Cynthia; Lyerly, Anne D; McKinney, Leslie C; Hatfield, Kimberly P; Baer, Gerri R; Sahin, Leyla; Nguyen, Christine P.
Affiliation
  • Sewell CA; Division of Urology, Obstetrics and Gynecology, United States Food and Drug Administration, Silver Spring, MD. Electronic address: catherine.sewell@fda.hhs.gov.
  • Sheehan SM; Duke-Margolis Center for Health Policy, Washington, DC.
  • Gill MS; Duke-Margolis Center for Health Policy, Washington, DC.
  • Henry LM; University of Maryland Francis King Carey School of Law and Johns Hopkins Berman Institute of Bioethics, Baltimore, MD.
  • Bucci-Rechtweg C; Novartis Pharmaceuticals Corporation, East Hanover, NJ.
  • Gyamfi-Bannerman C; Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Diego School of Medicine, San Diego, CA.
  • Lyerly AD; Department of Social Medicine and Center for Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, NC.
  • McKinney LC; Division of Pharmacology Toxicology for Rare Diseases, Pediatrics, Urology and Reproductive Medicine, United States Food and Drug Administration, Silver Spring, MD.
  • Hatfield KP; Office of Pediatric Therapeutics, United States Food and Drug Administration, Silver Spring, MD.
  • Baer GR; Office of Pediatric Therapeutics, United States Food and Drug Administration, Silver Spring, MD.
  • Sahin L; Division of Pediatric and Maternal Health, United States Food and Drug Administration, Silver Spring, MD.
  • Nguyen CP; Office of Rare Diseases, Pediatrics, Urology and Reproductive Medicine, United States Food and Drug Administration, Silver Spring, MD.
Am J Obstet Gynecol ; 227(6): 805-811, 2022 12.
Article in En | MEDLINE | ID: mdl-35934117
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biosimilar Pharmaceuticals / COVID-19 Type of study: Clinical_trials / Prognostic_studies Aspects: Ethics Limits: Adult / Female / Humans / Pregnancy Country/Region as subject: America do norte Language: En Journal: Am J Obstet Gynecol Year: 2022 Document type: Article Country of publication:
Fulltext
Add to My VHL
Print
XML
PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biosimilar Pharmaceuticals / COVID-19 Type of study: Clinical_trials / Prognostic_studies Aspects: Ethics Limits: Adult / Female / Humans / Pregnancy Country/Region as subject: America do norte Language: En Journal: Am J Obstet Gynecol Year: 2022 Document type: Article Country of publication: