API Warning Letters Each spring, the FDA publishes data on its website related to Form 483 inspection observations and warning letters issued by the Centre for Drug Evaluation and Research (CDER) during
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- Brexit – Implications For the Pharma Industry in Ireland The UK’s referendum decision to leave the EU in May 2016 undoubtedly sent shockwaves throughout Europe. European countries are still struggling to interpret what ‘Brexit’ will mean for them. Ireland,...
- EMA to Work With Stakeholders to Improve Product Information For EU Medicines The European Medicines Agency (EMA) has published an action plan to improve the product information (PI) for EU medicines, an information package for patients and healthcare professionals that accompanies every single medicine authorised in...
- Diaceutics Wins at Export Industry Awards Diaceutics, the Irish data insights and solutions company helping patients receive potentially lifesaving medicine through better testing, won the Small & Emerging Exporter of the Year Award at the recent Export...
- Brexit – Key Issues For the Pharmaceutical Industry Brexit – the stark reality is that the UK’s EU membership and the application of all EU legislation in the UK ends automatically at midnight on 30th March 2019! Current understanding...
- European Commission Diagnoses the State of Health in the EU Only by rethinking our health systems can we ensure that they remain fit-for-purpose and provide patient-centred care. This is what the 28 Country Health Profiles recently published by the Commission,...
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