Agency IQ

OCTOBER 20, 2023

.” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. The meeting featured presentations from four of the program’s awardees from FY22 and FY23, which included both internal and external researcher projects.

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Agency IQ

SEPTEMBER 29, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

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Agency IQ

JUNE 16, 2023

0910-AI78 June 2023 May 2023 Final Rule Stage Sunlamp Products; Amendment to the Performance Standard FDA is updating the performance standard for sunlamp products and ultraviolet lamps intended for use in these products to improve safety, reflect new scientific information, and work towards harmonization with international standards.

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Agency IQ

OCTOBER 27, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists.

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Agency IQ

DECEMBER 11, 2023

So far in 2023, the Office has co-authored fifteen guidance documents—the majority of which were drafts—offering insight into the agency’s thinking on several key policy issues, such as clinical trial diversity and the accelerated approval pathway. AgencyIQ has identified several major themes in the FDA’s oncology work.

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The Pharma Data

NOVEMBER 9, 2020

. “Our initial focus is to develop standardized drug formulations with precise, predictable and efficient API delivery for clinical study and therapeutic use.” ” Prof.

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Agency IQ

FEBRUARY 15, 2024

AgencyIQ has analyzed the agency’s guidance agendas, user fee commitment letters, statutory obligations and international efforts to determine which guidance documents the agency is actively working on this year (and in some cases, in the years ahead as well).

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