Antimicrobials

EU, Japan and US: a single development programme for new antibiotics

Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), met in Tokyo last month to plot out an approach that would allow drugmakers to conduct a single development plan for new antibiotics.

EDQM

EDQM publishes the final report of its Pharmaceutical Care Quality Indicators Project

The EDQM has just published the final report of its Pharmaceutical Care Quality Indicators Project.

EU USA handshake

Eight European drug regulatory authorities will be able to conduct FDA GMP inpsections

The U.S. Food and Drug Administration will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements.

Luigi De Rosa

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Bio-technologist with multidisciplinary expertise, enthusiastic and passionate about Pharmaceutical Quality Assurance.

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