Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. 6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., not discontinued) and are available for sale.

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Agency IQ

OCTOBER 6, 2023

For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. As AgencyIQ has previously discussed , developing biosimilars is an expensive process. Read the AgencyIQ analysis here.

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Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023.

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Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

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Agency IQ

OCTOBER 27, 2023

Circuit vacated the final rule in 2021. FDA finalized a ban on these devices in 2020, but the D.C. FDA previously determined that the use of ESDs for SIB and AB presents an unreasonable and substantial risk of illness or injury and that the risks associated with ESDs for these intended uses cannot be corrected or eliminated by labeling.

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Agency IQ

DECEMBER 1, 2023

Circuit vacated the final rule in 2021. FDA finalized a ban on these devices in 2020, but the D.C. FDA previously determined that the use of ESDs for SIB and AB presents an unreasonable and substantial risk of illness or injury and that the risks associated with ESDs for these intended uses cannot be corrected or eliminated by labeling.

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