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.

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Agency IQ

FEBRUARY 15, 2024

CDER, CBER Draft 12/29/2025 FDA must issue final guidance no later than 18 months after the close of the public comment period for draft guidance. Priority B List. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

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FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. The California Board of Pharmacy updated many of the application forms and guidelines in late 2024.

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Drug Target Review

APRIL 11, 2025

Carlos specialises in helping pharmaceutical and biotechnology companies develop their in- and out-licensing strategies, with additional expertise and experience in portfolio assessment and prioritisation, drug candidate valuation, valuation and related services. 2024 [cited 2025 Feb 7]. Velez (2025). Lifescienceleader.com.

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Drug Target Review

MARCH 13, 2025

Surveys (eg, 2024 State of Tech in Biopharma Report ) predict a doubling of R&D data year-over-year in 2025, highlighting the continued growth of available data. This article, along with other insightful analyses, will be featured in our upcoming report, Beyond the Lab – Artificial Intelligence, launching on 21st March 2025.

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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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FDA Law Blog: Biosimilars

MAY 13, 2025

FDA recognized that there are pharmacy websites that operate legally and offer convenience, privacy, and safeguards for purchasing medicines, but there are many that fail to adhere to safeguards followed by pharmacies licensed in the U.S. Unapproved prescription drugs present serious safety and effectiveness concerns.

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BioPharma Drive: Drug Pricing

JUNE 12, 2025

Published June 12, 2025 Amy Baxter Staff Reporter post share post print email license Win McNamee via Getty Images First published on The budget bill currently under consideration in Congress is big — and it’s complicated. By Jacob Bell • May 6, 2025 Keep up with the story. But the bill’s path forward is uncertain.

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