US FDA clarifies rules on expanded access to investigational drugs
This article was originally published in SRA
All applications for patients to receive an investigational drug under the US Food and Drug Administration's expanded access regulation must undergo a full review by an institutional review board, the agency has clarified in a draft guideline1,2. In a separate document, the FDA also explains the circumstances in which it may be appropriate for sponsors to charge patients for being allowed access to investigational drugs3,4.
You may also be interested in...
Expanded Access Cost Distribution: FDA Clarifies New Rules For Charging Patients
Revised draft guidance makes clear that sponsors may charge all patients a flat administrative fee to cover ‘startup’ costs, regardless of when they join.
Global Medtech Guidance Tracker: March 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-four documents have been posted on the tracker since its last update.
Final ICH Guide Supports Nonclinical Development Of Gene Therapy Products
The International Council for Harmonisation has finalized guidance that aims to facilitate the nonclinical and clinical development programs of gene therapy products, while avoiding the unnecessary use of animals.