Pink Sheet Podcast: Makena's Accelerated Approval Questions, Woodcock On Biobetters, Singulair's Safety Issues
Executive Summary
Pink Sheet reporters discuss the upcoming Makena advisory committee meeting, Janet Woodcock's recent comments on the biosimilar market, and options for new safety communications for Singulair.
You may also be interested in...
Gene Therapy: Pediatric Development Could Start Sooner Than Sponsors Think – FDA OTP Director
Nicole Verdun said children could participate in gene therapy clinical trials earlier if the necessary controls are in place.
CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings
FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.
Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?
EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.