IDE “Clinical Holds” Can Prompt Industry Request For FDA Rationale
This article was originally published in The Gray Sheet
Executive Summary
A final guidance on so-called 517A requests, in which companies can request a substantive summary of FDA’s rationale for certain decisions, puts an agency halt of a device trial on the list of actions that qualify for such a request. That is a new addition from the 2013 draft version.
You may also be interested in...
FDA Action-Item List Shows Plans To Revamp De Novo, Combo Product, QSR Regs, And More
Planned US FDA actions on the spring 2020 Agency Rule List show expected rules around de novo applications, and combination product classification and appeals – as well as the long-awaited Quality System Regulation overhaul.
Draft Guidance Addresses Company Requests For Rationale Of FDA Decisions
The document offers FDA’s interpretation of the terms “substantive summary” and “significant decisions,” both of which appear in new statutory provisions related to the longstanding process for manufacturers to appeal an agency decision.
As Casgevy, Lyfgenia Launches Proceed, CRISPR And bluebird bio CEOs Reassure
The CEOs of bluebird bio and CRISPR Therapeutics hope to inspire investor confidence that their gene-based therapies for sickle cell disease and beta thalassemia will be widely reimbursed in the US and EU.