Pink Sheet Podcast: FDA User Fees, Real-Time Oncology Review, ALS Accelerated Approval, Opioid Suit
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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Agency employees will have on-site, telework and remote possibilities, but options will depend on the center, office and job duties.
US FDA has 120 days to review generic sponsors’ requests for letters to help them obtain product samples, but will not send them to the reference product company.