RAPS

FDA updates guidance on expanded access for investigational drugs under IND

The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug (IND) application. The guidance now ...
JD Supra

Let It Grow: FDA Revises Q&A Guidance to Support Sponsors With the Implementation of Expanded Access Programs

“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 ...

FDA Green Lights Expanded Access to Pancreatic Cancer Drug, Daraxonrasib

Eligible patients in the expanded access program will be able to receive daraxonrasib from their healthcare provider ...
JD Supra

FDA Issues Updated Guidance on Expanded Access to Investigational Drugs

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 ...