STAT May 22, 2024
Thanks to new regulatory frameworks like the Food and Drug Administration’s Breakthrough Therapy designation, drugs are coming to market faster than ever. A 2024 analysis of drugs included in this program showed they had 23% shorter clinical development timelines than those that were not part of the program, with no negative effects on their safety profiles. This regulatory innovation is great for patients, pharmaceutical companies, health care providers, and the full health care landscape, getting new medicines to the people who need them in ever-shorter time.
Using real-world data to monitor drug safety and effectiveness adds an important capability to identify ways to improve patient and clinician experiences with a drug, based on side effects, adverse events, prescribing patterns, and...
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