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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

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. to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

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. to include devices. What ever happened to that thing?

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DEA Pharmacy Decision Highlights Agency’s Thinking on Expert Credibility and Testimony, as well as Red Flag Resolution

FDA Law Blog: Biosimilars

Hull A recent DEA decision revoking the registration of a Louisiana pharmacy sheds light on the Agencys approach to crediting one experts testimony over that of another expert during an administrative hearing. In Neumanns Pharmacy, LLC , 90 Fed. Whats the take away?