Exenatide Pregnancy Registry

Pregnancy Registry, Diabetes, BYETTA, byetta, Type 2 Diabetes

References

Food and Drug Administration
Guidance for Industry: Establishing Pregnancy Exposure Registries. US Dept of Health and Human Services, Food and Drug Administration, Rockville, Maryland 2002.
Food and Drug Administration
Guidance for Industry. Good Pharmacovigilance Reporting and Pharmacoepidemiology Practices.  US Dept of Health and Human Services, Food and Drug Administration, Rockville, Maryland. March 2005
Scheurle A, Tilson H.
Birth defect classification by organ system: a novel approach to heighten teratogenic signaling in a pregnancy registry. Pharmacoepidemiology & Drug Safety. 2002; 11: 465-475.
International Conference on Harmonization.
E6: Guideline for Good Clinical Practice, 1996. Accessed from http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html on January 9, 2012.
Centers for Disease Control and Prevention:
Metropolitan Atlanta Congenital Defects Program Procedure Manual.  July 1989 (Revised January 1998); A1-B11.  To obtain a copy of the MACDP Procedure Manual or Defect Code, send an email request to macdp@cdc.gov.
Correa A, Cragan J, Kucik J, et al.
Metropolitan Atlanta Congenital Defects Program 40th Anniversary Edition Surveillance Report:  Reporting Birth Defects Surveillance Data 1968-2003.  Birth Defects Research (Part A) 2007; 79:65-93.