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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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Pink Sheet Podcast: Monkeypox Vaccine EUA, Drug Pricing Bill Fallout, US FDA’s IT Upgrade

Pink Sheet reporters and editor discuss the new monkeypox vaccine EUA, the potential impact of drug pricing legislation, and how things may have been different if the FDA already had a desired technology upgrade.

Patient-Focused Drug Development Events May Be Giving Way To Small, Private Meetings With FDA

Patient listening sessions, which are easier to schedule, have overtaken traditional patient-focused drug development meetings in terms of volume, although US FDA’s data may be incomplete.

UPDATED: Who Can Sign US FDA EUAs? Expect Center Directors And Their Deputies Going Forward

Agency policy now allows several others, along with the FDA chief scientist, to authorize emergency use of products, including CBER Director Peter Marks, who signed the EUA for the modified dosing of the monkeypox vaccine.

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