About FDA
FDA Basic Video: Dianne Murphy Discusses Effective and Proper Uses of Medicines and Devices in Children (Video)
What is the Office of Pediatric Therapeutics?
Dianne Murphy, MD, is the Director of FDA’s Office of Pediatric Therapeutics (OPT). The mission of OPT is to enforce a Congressional mandate that assures access for children to innovative, safe and effective medical products. Historically, many medical products have not been tested for use in children, leading to an increase in adverse events and the use of ineffective products. “The Office of Pediatric Therapeutics is supposed to help the FDA work to develop the knowledge that is needed to use medicines and devices properly in children,” says Murphy. While the Office of Pediatric Therapeutics is taking significant steps by implementing regulatory science initiatives by working with small business and industry entities, Murphy explains that “…one of the biggest areas that remains almost completely unstudied is neonates to prematures.” She further notes that young children and neonates require the development of a new directional endpoint that can better help us to not treat children with our best guess, but with knowledge.
Show all related FDA Basics Questions
- Upcoming Webinar Tuesday, March 19th - Buyer Beware:The Risks and Dangers of Purchasing Drugs Online
- FDA Basics Metrics: April 2013
- When and why was FDA formed?
- How does FDA provide information about drug products currently under review for approval by the agency?
- Why are some drugs available as both a prescription and an over-the-counter drug?
- What does FDA do?
- What Should I Do If I See Violations of FDA’s Tobacco Products Rules?
- FDA Center for Tobacco Products Inaugural Year and Looking Forward
- What are FDA’s Regulations for Flavored Tobacco?
- What are the new Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents?
- What will FDA do to curb tobacco use among children and adolescents?
- What are some of the key regulatory timelines associated with the tobacco control act?
- How does the regulation of tobacco products differ from FDA’s regulation of drugs or medical devices?
- Is FDA going to ban tobacco?
- What products are not considered to be tobacco products as defined by the tobacco control act?
- What products are considered to be tobacco products as defined by the tobacco control act?
- What is the main goal in regulating tobacco products?
- What are the priorities of the Center for Tobacco Products?
- Does FDA have the authority to regulate tobacco products?
- What does FDA inspect?
- How is FDA organized?
- What does FDA regulate?
- FDA Basic Video: Lawrence Deyton Discusses Tobacco (Video)
- What part of FDA regulates tobacco products?
- FDA Basics Metrics: March 2013
How helpful was this information?
