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Article EMA Thank You What we expect European regulators to do in August and September 2024

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.

Regulations

Regulations Clinical Trials Production International

Analysis Life Sciences Thank You FDA lays out new assessment framework for certain nitrosamines

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.

FDA

FDA Science Production Regulations

Drug Discovery Digest

Article EMA Thank You What we expect European regulators to do in August and September 2024

Analysis Life Sciences Thank You FDA lays out new assessment framework for certain nitrosamines

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