Companion Diagnostics For Breakthrough Drugs Also Getting Swift Attention, FDA Says
This article was originally published in The Gray Sheet
Executive Summary
Device center officials cite a host of formal and informal actions available under existing legislative authority to ensure that development and review of companion diagnostics do not hinder the ability of FDA-designated breakthrough drugs from coming to market.
You may also be interested in...
CDRH’s Shuren Signals More Guidance, Enhanced Pre-Market Payer Role
In an interview, CDRH Director Jeffrey Shuren detailed plans for new guidance documents and process changes at the device center focused on IDE reviews, clinical testing requirements and pre-submission interactions with payers based on recommendations from the center’s entrepreneurs-in-residence program.
A “Breakthrough” Reality Check: Sponsors Seek FDA Flexibility On Manufacturing, Diagnostics
FDA’s much-anticipated guidance on expedited programs for drug development fills in some blanks on the new breakthrough designation, but simply advising sponsors they will need to pick up the pace on manufacturing plans and development of companion diagnostics leaves aspiring applicants wanting more, stakeholders said at DIA.
“Breakthrough Therapy” Development Speed May Be Tempered By Manufacturing Hurdles
Sponsors and FDA also will have to work through issues related to companion diagnostics to prevent treatments designated under the FDASIA’s new expedited development pathway from being delayed. Harmonization with foreign regulators is essential to making the pathway work, stakeholders say.