FDA Cites Clinical Investigator In Six Trials Of Three Cystic Fibrosis Drugs
FDA's oversight of clinical trials is becoming an increasingly significant factor in regulatory delays for some products, and a recent warning letter could have a very broad impact: it cites a clinical investigator for six trials related to three separate NDAs
You may also be interested in...
Cystic Fibrosis Trial Endpoints May Be Revised Following FDA Workshop
Quality-of-life metrics deserve consideration in addition to lung function in the development of aerosolized antimicrobials, researchers say.
Venture Philanthropists Say "Welcome To The Table" At Partnering Conference
Venture philanthropists have clearly been expanding their role in funding drug development beyond the basic research phase. Now, they want to collaborate more aggressively with traditional biopharma deal-makers, and an ambitious conference, FasterCures, recently organized in New York, took a step toward that goal. The organizers created a meeting based on a mixed format, which was comfortable for its diverse attendees - patient advocates, academics, and investors - yet drove the message: let's get something done
This Little Pig-Free Product Goes To Market? Alnara's High Hopes For A PERT
Alnara claims its latest trial shows real-world effectiveness of liprotamase, formerly called Trizytek, and plans early 2010 NDA.