Tag: Post market surveillance

While the vast majority of drugs remain on the market, one study of drugs approved between 1990 and 2009 found that 4.2% were eventually withdrawn for safety reasons. However, answering the question of what percent of FDA approved drugs are pulled requires understanding the complex landscape of post-market drug safety actions, which includes not just full withdrawals but also recalls and black box warnings.

The PBRER submission schedule is not a single, fixed timeline but varies based on factors like a drug's lifecycle, with new products requiring more frequent reports initially before transitioning to less frequent intervals. This variable reporting frequency is a cornerstone of modern pharmacovigilance and directly addresses the question of **How often is PBRer submitted?**.