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. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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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.

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12/29/2025 FDA must issue final guidance no later than 18 months after the close of the public comment period for draft guidance.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

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Drug Channels

MARCH 18, 2025

I am pleased to announce that Drug Channels Institutes new 2025 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers is now available for purchase and immediate download. Pharmacies and Pharmacy Benefit Managers. 2006-2025 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company.

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Drug Channels

JANUARY 13, 2025

This exclusive event will be held from March 17 to 19, 2025, at the Turnberry Resort and Spa in Miami. Registered attendees include senior executives from pharmaceutical manufacturers, pharmacy benefit managers, health systems, physician practices, pharmacies, wholesalers, and more. drug channels. I hope you can join us!

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Drug Channels

DECEMBER 12, 2024

This week, Im rerunning some popular posts while I prepare for tomorrows Drug Channels Outlook 2025 live video webinar. However, provider pushback has limited specialty pharmacies' share gains, so that buy-and-bill remains the most common channel for these products. Click here to see the original post from September 2024.

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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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