FARMA NEWS & TRENDS . Junho

FARMA NEWS & TRENDS . Junho

Mais uma edi??o com a compila??o das publica??es e notícias mais relevantes . Boa leitura !

First implementing regulation ((EU) 2024/1381) by the European Commission pursuant to the HTA Regulation ((EU) 2021/2282)

TRS 1052 – Annex 2: WHO good manufacturing practices for excipients used in pharmaceutical products

8th notified bodies survey on certifications and applications (MDR/IVDR)

FDA GUIDANCE: Remanufacturing of Medical Devices

New guidance for medical devices used in combination with medicines

Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)

New version of EUDAMED user guide UDI Devices

Commission presents a new project that looks at combined studies. COMBINE CTR-IVDR-MDR . ANALYSIS PHASE REPORT

OECD – OCDE issued a report on artificial intelligence in health

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