Agency IQ

JANUARY 4, 2024

Citizen petitions have raised the alarm regarding benzene in recent years, leading to FDA action Valisure, an analytical pharmacy that first alerted the FDA to concerns associated with nitrosamine impurities , recently set its sights on benzene impurities.

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Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The rule, will also, if finalized, address communication with State boards of pharmacy. Read our analysis of that rule here and here. ]

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025. What ever happened to that thing?

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National Institute on Drug Abuse: Nora's Blog

JANUARY 6, 2025

8 Currently in the United States, methadone is only available from specialized opioid treatment centers, but studies piloting access through pharmacies have shown promise. Together, we turn our eye to 2025 and the challenges and opportunities ahead.& Risk of dying was similarly low for both groups.

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FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

temporary exceptions from some of the requirements of the Ryan Haight Act of 2008) are extended for an additional year, until December 31, 2025. Thankfully, we have until December 31, 2025 to ruminate about it. The federal telemedicine flexibilities (i.e.,

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