Final Contrast Imaging Guidance Addresses Some, Not All, Industry Critiques
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's guidance on the intersecting regulatory pathways of imaging devices and contrast agents clarifies what marketing submissions are needed for various types of product changes, but still does not address data requirements for specific indications, such as breast cancer imaging.
You may also be interested in...
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.
One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says
Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.
Otsuka Busulfex's Overall Survival Claim Does Not Survive CDER Advertising Scrutiny
Statistical analyses based on pivotal trial data and used to promote a drug must prove what they purport to prove, FDA's Office of Prescription Drug Promotion says in an NOV letter to Otsuka over a website for the leukemia drug Busulfex (busulfan).