The FDA’s Rare Pediatric Disease Designation program aims to encourage development of therapies for serious diseases primarily affecting individuals under 18 years of age. If a New Drug Application ...

In this study, we have looked at enhancing tumor uptake and intracellular delivery of gold nanoparticles (AuNPs) while reducing the systemic exposure by systematic evaluation of the impact of ...

Intranasal (IN) drug delivery has proven to be a significant benefit over other routes of drug administration due to enhanced bioavailability in the brain. Because the BBB prevents various medications ...

The Department of Health and Human Services and the Food and Drug Administration announced on Tuesday a series of measures to phase out eight artificial food dyes.

In its response to Moleculin’s Initial Pediatric Study Plan, the FDA recommended including patients as young as 6 months old, younger than the company’s proposed minimum age of 2 years. The agency ...

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the ...

Here’s what food and drug regulation might look like under the Trump administration Leaders of the FDA have published a list of new priorities for the agency.