Washington, D.C.-Pressure to uncover potential adverse events before a new drug reaches patients seems to be taking a toll on drug development and marketing. The Food and Drug Administration (FDA) approved only 19 innovative new drugs in 2007, according to preliminary analyses. That's way down from the peak of 53 new drugs in 1996, but in line with a steady decline in new drug approvals since 2002.
Pharmaceutical companies believe this trend reflects a "new environment" at FDA that has raised the bar for new drug approvals. FDA reviewers routinely request additional studies, according to R&D executives, and delays in launching new products are common. One industry response is to seek more new indications for existing medicines, particularly expensive biologics. FDA officials claim that they have not changed standards, but have become better at detecting safety problems, especially for drugs to treat chronic conditions.
Extending the Capabilities of the EHR Through Automation
August 2nd 2023Welcome back to another episode of "Tuning In to the C-Suite," where Briana Contreras, an editor of Managed Healthcare Executive, had the pleasure of chatting with Cindy Gaines, chief clinical transformation officer at Lumeon.
Listen
Automate Your Practice's Workflows with These 5 Tools
October 4th 2023To maintain patient satisfaction and regulatory compliance and reduce potential clerical errors while maintaining high productivity, you can ease your staff’s burdens by automating your practice’s workflows and empower your staff to do more in less time.
Read More