Coverage

The head of the Food and Drug Administration has asked for a review of the agency’s food and tobacco programs following months of criticism over their handling of the baby formula shortage and e-cigarette reviews.
A shakeup of the chain of command at the FDA may be coming, but the beginning of the release of details is at least 60 working days away. FDA Commissioner Dr. Robert Califf told Food Safety News today that the agency has hired an outside…
The Food and Drug Administration has commissioned a review of its food and tobacco programs following public outrage over baby formula  shortages and concerns about flavored nicotine products. Dr. Robert Califf, the head of the F.D.A., said the…
Patient organization exploring development of a multi-stakeholder forum on real world evidence that, among other things, could address research questions posed by the Centers for Medicare and Medicaid Services in its national coverage determination for…
If the proposed Advanced Research Projects Agency for Health is created, new treatment candidates would need to engage with FDA early on to help determine appropriate clinical testing design, FDA principal deputy commissioner Janet Woodcock said Monday…
-Global Genes, a leading rare disease patient advocacy organization, today announced its 7th annual 
While the US Food and Drug Administration (FDA) began the process of modernizing its IT systems before the COVID-19 pandemic, the crisis accelerated much of that work and allowed the agency to streamline much of its activities at a critical moment in…
In partnership with the Reagan-Udall Foundation, the FDA and the Friends of Cancer Research launched the Evidence Accelerator (EA) to advance the use of Real-World Data (RWD) to inform the COVID-19 response. In collaboration, ODT and the FDA’s Office of…
Strategies to expand access to naloxone (Narcan) for the prevention of opioid overdoses were explored during a webinar hosted by the Reagan-Udall Foundation for the FDA on Tuesday. Over 100,000 people died from drug overdoses over a 12-month…
FDA and the Reagan-Udall Foundation will hold a virtual meeting on March 29 to discuss strategies to increase access to naloxone, the opioid overdose reversal drug. Read the full story here.