Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Regulations Clinical Trials Production International 40

Agency IQ

JUNE 7, 2024

FDA’s new guidance explains what to do during a BIMO inspection Under the FDA’s Bioresearch Monitoring (BIMO) program, the agency oversees the operation of regulated research. In short, the BIMO program oversees regulated research – both human and animal – in a variety of ways. the first day of federal fiscal year 2025).

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FDA Compliance Regulations Production 40

Agency IQ

AUGUST 11, 2023

drug supply, manufacturers should conclude a risk assessment of approved or marketed products within 6 months of publication of this guidance,” FDA added, with confirmatory testing intended to be concluded within 3 years. Since this discovery, it’s been unclear how regulators or sponsors might assess or address these potential risks.

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FDA Science Production Regulations 40