How does the FDA handle adverse effects reported for approved products?
Once a product is on the market, the FDA continues to monitor its safety through various post-market surveillance programs. The MedWatch system is the FDA's medical product safety reporting program, where healthcare professionals and consumers can report adverse effects. The FDA analyzes these reports to identify potential safety concerns and can take regulatory actions if necessary, such as issuing warnings, mandating label changes, or even withdrawing a product from the market.