FDA Says "Agreement" Does Not Have To Be Holy Grail Of SPA Discussions
The next reauthorization of the Special Protocol Assessment process could de-emphasize the idea that an SPA is an "agreement" with FDA
You may also be interested in...
Special Protocol Assessment Draft Guidance Adds Biosimilars, Not Much Clarity
SPA can be terminated by 'substantial scientific issue,' FDA tells industry, but notes that it only happens less than one percent of the time.
FDA Makes It Formal, Rescinds SPA For Amarin’s ANCHOR Study
Agency makes clear that triglyceride levels are no longer an acceptable surrogate for reducing cardiovascular risk.
Northera Review Shows Regulatory Challenges In Difficult Therapeutic Space
Chelsea Therapeutics’ development program for droxidopa in neurogenic orthostatic hypotension led to discussion at a recent advisory committee meeting about the role of Special Protocol Assessments and appropriate validation of patient-reported outcome instruments.