Pink Sheet Podcast: FDA User Fees, Real-Time Oncology Review, ALS Accelerated Approval, Opioid Suit
Executive Summary
Pink Sheet reporter looks at the biggest US FDA and pharma industry stories of the week, including the status of US FDA user fee renewal legislation, new real-time oncology review program guidance, Biogen’s ALS accelerated approval play, and Teva settling opioid litigation.
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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.