Pharmaceutical companies and research advocacy groups are asking the US Food and Drug Administration (FDA) to clarify some of the provisions of its recently updated expanded access draft guidance.
Families, first responders, and bystanders who witness an opioid overdose now have more than one naloxone nasal spray they ...
The U.S. Food and Drug Administration (FDA) has issued updated guidance on Expanded Access to Investigational Drugs for Treatment Use, clarifying how drug developers, physicians, and patients can ...
“Let it grow, let it blossom,” said Eric Clapton, and so the Food and Drug Administration expects of expanded access programs with the issuance of its guidance on “Expanded Access to Investigational ...