US FDA Special Protocol Assessment Draft Guidance Adds Biosimilars But Not Much Clarity
This article was originally published in SRA
Revisions proposed by the US Food and Drug Administration to its guidance on special protocol assessments (SPAs) reiterate that the agency is not bound by these agreements on the design and size of clinical trial programs. In addition, they clarify for the first time the situations in which the agency may revoke an agreement.
You may also be interested in...
The meetings are tied to requirements from the 2016 21st Century Cures legislation. They could offer more development certainty for sponsors by allowing informal agreements with the agency on pre- and post-market issues.
Cures legislation offers more development certainty for sponsors by allowing informal agreements with the agency on pre- and postmarket issues.
Senators ask the agency to address the “regulatory loophole” permitting telehealth companies to promote prescription drugs without disclosing side effects and question if FDA has enforcement authority over third-party social media influencer promotions.