FDA has released a draft guidance which lays out a framework for the agency’s response to post-marketing safety issues. These issues include serious adverse events, product quality issues and medication errors. FDA has also drafted a ranking system to help prioritize each issue that comes up based on its level of risk. The FDA has been criticized over the last 18 months for not properly monitoring its own adverse event reporting (AER) database effectively. A study published in Medical Care in January found that some FDA drug risk communications had a strong immediate impact but many others had a delayed or nonexistent impact on both healthcare utilization and health behaviors. To read more, click here.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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