The European Commission has proposed targeted reforms aimed at simplifying rules for medical devices. The proposed reforms are part of a package of measures put forth by the Commission this week to ...

The US Food and Drug Administration (FDA) has finalized two guidances for sponsors and investigators regarding adverse event reporting for drugs, biologics, and medical devices in clinical studies.

The US Food and Drug Administration (FDA) has finalized guidance on patient-focused drug development (PFDD), outlining approaches for sponsors to select, modify, and evaluate clinical outcome ...

We zullen toezichthouders en zorgprofessionals uit België en Nederland samenbrengen om kennis uit te wisselen en te netwerken over MDR artikel 5.5 ...

ROCKVILLE, MD @ Robert Lionberger, director of the US Food and Drug Administration@s (FDA) Office of Research and Standards (ORS) within the Office of Generic Drugs (OGD), emphasized the critical need ...

This article discusses the impact of US state laws banning food ingredients. It examines two recently enacted state laws that require a warning or disclosure statement on the label, but do not ...

Medical device and pharmaceutical industry groups in the EU and US are urging significant changes to the EU@s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Europe@s ...

The US Food and Drug Administration (FDA) will only conduct vital and mission critical activities amid a government shutdown that began Wednesday after Congress failed to reach a deal to fund the ...

The US Food and Drug Administration has listed more than half a dozen research areas related to generic drug development and authorization that it plans to prioritize in FY 2026. The agency@s ...

Several stakeholders have raised concerns that parts of the US Food and Drug Administration@s (FDA) draft guidance on unique device identifier (UDI) requirements for combination products are ...

The US Food and Drug Administration (FDA) has published three draft guidances on developing cell and gene therapies (CGT) to treat rare diseases, conducting postapproval CGT studies, and using the ...

Some of the main reasons the US Food and Drug Administration (FDA) rejects applicants from participating in its Advancing Real-World Evidence (RWE) Program include concerns that proposed real-world ...