Topic
Expanded Access
5 published works
Focus on Regulation
FDA’s ‘Project Facilitate’ Pilot to Collect Metrics on Sponsor Expanded Access Denials
By Robert Church, Jane Kalinina
This morning, FDA announced it launched its new expanded access pilot called “Project Facilitate,” a concierge call center under the Oncology Center of Excellence (OCE) to facilitate the Single Patient…
Focus on Regulation
FDA Simplifies and Clarifies Expanded Access Program
By HL Pharmaceutical & Biotechnology Team, Robert Church, Heidi Gertner, Bert Lao
Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive…
Focus on Regulation
Short-Fuse Compliance Deadline for Expanded Access Provision in 21st Century Cures Act
By Robert Church, Meredith Manning, Justin Yu
Under Section 3032 of the 21st Century Cures Act, manufacturers and distributors of investigational drugs for serious diseases or conditions have 60 calendar days after the date of enactment to…
Focus on Regulation
FDA June 2, 2016 Final Guidances For Industry
On June 2, 2016, FDA issued three final Guidances for Industry—two of the three are aimed at clarifying the expanded access applications and procedures, while the third discusses charging for…
Focus on Regulation
FDA Issues Simpler Draft Form for Individual Patient Expanded Access Applications
By Robert Church, Heidi Gertner, Sari Bourne
On February 4, 2015, the Food and Drug Administration (FDA) issued a new Draft Guidance titled Individual Patient Expanded Access Applications: Form FDA 3926. The Draft Guidance introduces draft Form…