In-line/Post-Market Drugs
What are in-line/post-market drugs?
In-line or post-market drugs are those that have completed clinical trials, received FDA approval, and are now available for public use. These drugs are intended to treat, manage, or prevent health conditions or their symptoms and are accessible to patients through healthcare providers.
Why must biopharma companies continue to monitor post-market drugs?
Even after a drug has been approved and is on the market, it requires ongoing monitoring through a process known as post-market drug surveillance. This is crucial because, while extensive clinical trials assess safety and efficacy in controlled settings, post-market surveillance provides valuable insights into the drug’s performance in a broader population under real-world conditions. This continued monitoring helps identify any potential long-term effects, rare side effects, or issues that may not have been evident during clinical trials.
Post-market drug surveillance can lead to important updates regarding the drug’s safety profile, which might affect marketing strategies or necessitate changes to the drug’s formulation or usage guidelines to ensure continued effectiveness and safety.