How does FDA monitor safety after drugs are approved and marketed?
FDA's safety assessment of medicines does not diminish after drugs are approved for marketing. Although the premarket phase of study is very intensive, much work still remains to monitor approved drugs over time. No drug is risk-free, and it is not uncommon for new information to be discovered after a drug is on the market and being used by larger numbers of patients. Such information helps provide a better picture of drug risks, enables FDA to give health care professionals and patients the latest information on potential or newly identified risks, and strengthens FDA's ability to safeguard patients against unacceptable risks.
In recent years, FDA's Center for Drug Evaluation and Research (CDER) has taken many steps to enhance the quality, accountability, and timeliness of its postmarket drug safety decisions. As a result, the Agency now oversees the safety of marketed drugs with the same emphasis it has for premarket drug review. These efforts include the development of important new scientific tools to enhance detection of potential drug safety issues that occur once a drug is on the market and new methods for planning, managing, tracking, and communicating about those issues.
Visit this link for a complete 21-page April 2012 report of FDA's Center for Drug Evaluation's work to enhance the Agency's postmarket drug safety. Visit this link for a six-page highlights version of the same report.
- FDA Basics Metrics: December 2014
- FDA Basics Webinar: FDA CBER Mini-Sentinel Program
- Recall Process for FDA-Regulated Products
- FDA Basics Metrics: November 2014
- FDA Basics Webinar - November 24, 2014: Drug Shortages
- FDA's MedWatch Program: Voluntarily Reporting Problems to the FDA
- FDA Basics Webinar June 30, 2014: Over-The-Counter Medicines and Driving
- Webinar Friday, May 23 - Packing A Healthy Lunch
- Webinar Tuesday, May 13 - Temporary Tattoos: Raising Consumer Awareness of Safety
- FDA Basics Webinar November 5, 2014: CVM’s Pet Food Reporting and Recall Process
- FDA Basics Metrics: October 2014
- FDA Basics Metrics: Septemeber 2014
- Who can I contact if my question wasn’t answered or if I have additional questions in the future?
- What Should I Do If I See Violations of FDA’s Tobacco Products Rules?
- FDA Basics Metrics: August 2014
- FDA Basics Metrics: July 2014
- FDA Basics Metrics: June 2014
- Where do I go to report problems with flea and tick products?
- What does FDA regulate?
- FDA Basics Metrics: May 2014
- FDA Basics Metrics: April 2014
- Who can I contact if my question wasn’t answered or I have additional questions in the future?
- FDA Basics Metrics: March 2014
- FDA Basics Metrics: February 2014
- What is the Reportable Food Registry?
How helpful was this information?