The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.”

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FDA - Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of BIMO Inspections

6th June 2024

Guidance document open for comment.

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FDA Roundup: 4th June 2024

6th June 2024

An at-a-glance summary of news from around the agency.

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ICH - M12 Guideline reaches Step 4 of the ICH Process

6th June 2024

The ICH M12 Guideline “Drug Interaction Studies” and “Drug Interaction Studies Questions and Answers” reached Step 4 of the ICH Process on 21 May 2024.

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EMA - Horizon scanning on veterinary novel therapies

30th May 2024

The European Medicines Agency has launched a horizon scanning survey on veterinary novel therapies.

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EMA - One Health: How EU agencies are tackling environmental and public health together

23rd May 2024

On 22nd May 2024, the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda in the European Union (EU).

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