FDA’s Califf backs limited use of single-arm trials, but says regulatory pathways for some cancers should 'move into a new phase'

July 29, 2022 7:10 am

https://www.fiercebiotech.com/biotech/fdas-califf-says-many-cases-regulatory-pathways-cancer-should-move-new-phase

Post navigation

← Previous Post

What They Said – FDA Press Releases Mid-2021

Leave a Comment / Biotechnology, FDA, Medical Device, Regulatory Affairs / By MedicalInnovationExchange

It has been a regular feature of the blog to give a read on what…

Crisis Communications and FDA

Leave a Comment / Biotechnology, FDA, Medical Device, Regulatory Affairs / By MedicalInnovationExchange

In the face of a crisis situation, it is a given that the clarity and…

AdComms – Is FDA Getting Less Advice?

Leave a Comment / Biotechnology, FDA, Medical Device, Regulatory Affairs / By MedicalInnovationExchange

As more drugs are being approved, is FDA getting less advice than in the past?…

FDA Authorizes Third Dose – Some Implications

Leave a Comment / Biotechnology, FDA, Medical Device, Regulatory Affairs / By MedicalInnovationExchange

What does “fully vaccinated” mean today? In the face of the widening spread of the…

How your healthcare business can generate more leads

Leave a Comment / Consulting, FDA, Medical Device, MedTech / By MedCity News

MedCity News has launched the Knowledge Hub to help you get targeted healthcare leads and…

Medtronic expands recall of MiniMed insulin pumps

Leave a Comment / Consulting, FDA, Medical Device, MedTech / By Elise Reuter

Medtronic is recalling its MiniMed 670G system after reports of broken retainer rings for insulin…

This startup wants to build a needle-free CGM using nanotechnology

Leave a Comment / Consulting, FDA, Medical Device, MedTech / By Elise Reuter

Graphwear co-founders Saurabh Radhakrishnan and Rajatesh Gudibande want to make CGMs that use nanotechnology to…

Sepsis: Treating a global health crisis at the point of care

Leave a Comment / Consulting, FDA, Medical Device, MedTech / By Avishay Bransky

A major global health crisis that we find ourselves facing today is sepsis – the…

FDA Online Courses

E-Learning

MedX Forum

Moderators

News & Blog