Women's Health Issues
Volume 18, Issue 4 , Pages 226-228 , July 2008

An Innovative Approach to Determine Fetal Risk: The FDA Office of Women's Health Pregnancy Exposure Registry Web Listing

  • Pellavi Sharma, MPH

      Affiliations

    • Corresponding Author InformationCorrespondence to: Pellavi Sharma, MPH, 5600 Fisher's Lane, Parklawn Building, Room 16-6 HF-8, Rockville, MD 20857.
    • Pellavi Sharma, MPH, is an ORISE Research Fellow with the FDA Office of Women's Health.
    • ,
  • Ameeta Parekh, PhD

      Affiliations

    • Ameeta Parekh, PhD, is Director of the Research and Development Program in the Office of Women's Health. The office of Women's Health Mission is to protect and advance the health of women through policy, science and outreach and to advocate for the participation of women in clinical trials for sex, gender and subpopulation analyses.
    • ,
  • Kathleen Uhl, MD

      Affiliations

    • Kathleen Uhl, MD, is the Assistant Commissioner for Women's Health at the Food and Drug Administration.

Received 21 September 2007 ,Accepted 20 February 2008.

References 

  1. 21 Code of Federal Regulations (CFR). 201.57 (f). www.access.gpo.gov2007;Accessed July 30 2007
  2. Battino D. Assessment of teratogenic risk. Epilepsy Research. 2001;45:171–173
  3. Centers for Disease Control and Prevention (CDC). PRAMS and unintended pregnancy. www.cdc.gov/prams/UP.htm2007;Accessed July 30 2007
  4. Centers for Disease Control and Prevention (CDC). Medication use during pregnancy and while breastfeeding: Fast facts, meds and breastfeeding. www.cdc.gov/ncbddd/meds/fast.htm2007;Accessed July 30 2007
  5. Epilepsy Foundation. Pregnancy and epilepsy. www.epilepsyfoundation.org2007;Accessed July 30 2007
  6. Food and Drug Administration (FDA). Reviewer guidance: Evaluating the risks of drug exposure in human pregnancies. www.fda.gov/cder/guidance/6777fnl.htm2005;Accessed July 30, 2007
  7. Food and Drug Administration (FDA)Center for Drug Evaluation and Research. (n.d.). Drugs@FDA. www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfmAccessed July 30, 2007
  8. Food and Drug Administration (FDA). Guidance for industry: Establishing pregnancy exposure registries. www.fda.gov/cder/guidance/3626fnl.htm2002;Accessed July 30, 2007
  9. Kennedy D, Uhl K, Kweder S. Pregnancy exposure registries. Drug Safety. 2004;27:215–228
  10. Koren G, Bologa M, Long D. Perceptions of teratogenic risk by pregnant women exposed to drugs and chemicals during the first trimester. American Journal of Obstetrics and Gynecology. 1989;160:1190–1194
  11. Pole M, Einersan A, Pairaudea N. Drug labeling and risk perceptions of teratogenicity: A survey of pregnant Canadian women and their health professionals. Journal of Clinical Pharmacology. 2001;40:573–577

PII: S1049-3867(08)00033-9

doi: 10.1016/j.whi.2008.02.006

Women's Health Issues
Volume 18, Issue 4 , Pages 226-228 , July 2008

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