FDA Law Blog: Biosimilars

MARCH 24, 2025

Houck In August 2023, the U.S. In January a public hearing began to receive factual evidence and testimony on whether marijuana should be rescheduled. By Larry K. Department of Justice subsequently conducted a separate Eight Factor Analysis and concurred with HHS rescheduling recommendation.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. But could it be a busy month for rulemaking?

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FDA Law Blog: Biosimilars

MARCH 29, 2024

That report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony. Complete numbers for 2023 and 2024 are not available, but it appears that FDA was only able to complete 537 BIMO inspections in 2022. The vast majority are for drugs.

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Agency IQ

MARCH 1, 2024

In September 2023’s version of the FY 2024 contingency plan , the agency stated that 81% of staff would be retained: “15,602 (81%) of FDA staff will be retained including 12,300 (64%) who are exempt (their activities or position are already funded or otherwise exempted) and 3,302 (17%) who are excepted.” The longest shutdown in U.S.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JULY 28, 2023

Everything the FDA is planning to do in Q3 2023 The third quarter of the 2023 calendar year is shaping up to be one of the busiest periods of regulatory policymaking at the FDA in at least the last decade. Notably, one aspect of its transition plan will come into effect on August 9, 2023.

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FDA Law Blog: Biosimilars

APRIL 8, 2024

In 2022, the Government Accountability Office (GAO) reported that FDA needed to improve its foreign inspection program and that report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony. Finally, on October 3, 2023, DEA published an increase to the methylphenidate APQ.

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