4053.1 Informed Use of Medicines in Children and Pregnant Women: Overcoming the Challenges

Tuesday, October 30, 2012: 8:30 AM - 10:00 AM
Oral
Protecting and promoting child and maternal health in the changing regulatory environment of drugs will be discussed by FDA officials. Their topics include: How new regulations affect efforts to integrate pediatric patients into the drug development process. Ways to obtain data regarding medication use in pregnant women and nursing mothers from the view of scientific and regulatory demands during drug development. Facilitating access to appropriate therapies for women and newborn children through developing therapies.
Session Objectives: 1) Identify current laws and regulations that govern pediatric and maternal medicine. 2) Evaluate the success of including children in clinical trials. 3) Discuss the challenges and requirements for inclusion of pregnant women in clinical trials.
Organizer:
Rosemary Addy, MHS
Moderator:
Lynne Yao, MD
Discussant:
Carrie Ceresa, Pharm D, MPH

8:30am
Informed use of medicines in children and pregnant women: Overcoming the challenges
Rosemary Addy, MHS, Carrie Ceresa, Pharm D, MPH, Lynne Yao, MD and Susan McCune, MD
     

See individual abstracts for presenting author's disclosure statement and author's information.

Organized by: Medical Care

CE Credits: Medical (CME), Health Education (CHES), Nursing (CNE), Public Health (CPH)

See more of: Medical Care
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