What is the role of FDA's Office of Orphan Product Development and Office of New Drugs?
Nearly 30 million individuals are affected by rare diseases in the United States. A disease is considered rare if it affects fewer than 200,000 within the United States and there are more than 7000 such diseases and conditions. Rare diseases in childhood can be debilitating and require lifelong care. FDA’s Office of Orphan Product Development and Office of New Drugs facilitate the development and improve availability of treatment products for all patients including children with rare diseases.
Here are the resources to help you to find out more about orphan drug development:
- FDA Basics Metrics: February 2015
- FDA Basics Metrics: January 2015
- FDA Basics Webinar - November 24, 2014: Drug Shortages
- FDA's MedWatch Program: Voluntarily Reporting Problems to the FDA
- What is the Reportable Food Registry?
- How do I report a complaint about food bought in a supermarket?
- What Rules Apply to Persons that Want to Start a Food Business?
- Is "over the counter (OTC)" medication safe for my child?
- What is the FDA doing to protect children from tobacco?
- FDA Basics Webinar: Picnic Food Safety, How Safe is Your Picnic?
- Upcoming Webinar Tuesday, March 19th - Buyer Beware:The Risks and Dangers of Purchasing Drugs Online
- What device can I use to monitor the blood sugar level in my child?
- What is FDA doing to lower/reduce the risk of childhood obesity?
- Is it true that "OTC ( Over the Counter)" products can prevent SIDS?
- How can you detect lead levels in your child?
- Is it safe for your child to use a cell phone?
- What should parents be aware of before administering medication to a child?
- How does the FDA collect vaccine safety information?
- What is the role of FDA's Office of Orphan Product Development and Office of New Drugs?
- What are the potential risks to my child after exposure to radiological imaging?
- FDA's Pesticide Program
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