DRAP has based the draft guideline on the World Health Organization (WHO) Annex 9 Model guidance for storing and transporting ...

The US Food and Drug Administration has finalized a guidance that allows some manufacturers to submit 510(k) applications for ...

I’m skeptical that the QMSR will be finalized by December,” Eric Henry, senior quality and regulatory compliance advisor at ...

The US Food and Drug Administration (FDA) has made several changes to its guidances for transitioning medical devices and ...

Two upcoming International Council on Harmonization (ICH) guidelines covering stability testing and specification setting are ...

This ‘one-trial’ approach maintains efficiency in drug development and can provide early access to a drug using the ...

The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital ...

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...

The head of the US Department of Health and Human Services (HHS) is asking lawmakers for additional authorities to track ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

The US Food and Administrations (FDA) on Thursday finalized guidance defining what constitutes suspect and illegitimate ...