Keeping Track of Traceability – Preparing for the EU Medical Device Regulation

Aug 6, 2018

Under the FDA (Food & Drug Administration) rule in the USA, manufacturers have been required to implement UDI (unique device identification) on all medical product packaging since September 2014. European manufacturers of medical devices will now face even tougher regulations to ensure their products are safe to use under new EUlaws that are scheduled to come into effect from May 26, 2020. With this legislation coming into effect, Volker Watzke from Domino explains that manufacturers now have a responsibility to invest in a coding solution that allows them to apply traceability codes onto products as well aspackaging. ...

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Regulatory Trends and Developments in the Pharmaceutical Industry in 2018

Aug 6, 2018

In the 2017 fiscal year, the FDA issued 114 warning letters to pharmaceutical manufacturers contravening Current Good Manufacturing practices (cGMPs). This followed a trend of continual increase in warning letters, with 102 issued in FY2016 and 42 issued in FY2015. Though this rise suggests that pharmaceutical companies are slacking in the field of compliance, it is more likely to be a reflection of increased scrutiny within the FDA and of evolving areas of focus. In this article, Jennifer Lopez from Maetrics explores why this is the case, and looks at lessons learnt from this increased scrutiny. ...

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Navigating Risk Management Plans (RMPs) in the Evolving Regulatory Landscape

Aug 6, 2018

Pharmacovigilance (PV) is a vital part of healthcare and for monitoring the benefit-risk profile of medicinal products. The purpose of the European Medicines Agency’s (EMA’s) risk management plan (RMP) is to “document the risk management system considered necessary to identify, characterise and minimise the important risks of a medicinal product” and thus to help sponsors plan their PV and risk minimisation strategy. This article, by Dr Prashant Dhanavade from Sciformix, explores the continuously changing regulations and procedures in PV worldwide. ...

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Strategies Adopted by Branded Drug Manufacturers against Para IV Filers

Aug 6, 2018

This article by Trishna Chetry, T.M. Pramod Kumar, M.P. Venkatesh and Balamuralidhara V. from JSS College highlights the complex and critical regulatory strategies adopted by branded drug manufacturers against ParagraphIV filers in the past. The Hatch-Waxman Act 1984, also known as the Drug Price Competition and Patent Term Restoration Act, grants generic manufacturers the ability to challenge a patent without risking enormous damages from any possible infringement. The idea behind this incentive was to encourage generic firms to invalidate and challenge bad patents. As an outcome, patent infringement and a 30-month FDA stay period became a common scenario. ...

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Trends in Drug Development – In Denmark and Globally

Aug 6, 2018

The entire process from discovering and developing a potential drug candidate to its delivery into the human body requires comprehensive knowledge about the root cause of the disease at molecular, cellular and genetic levels, and can be a costly and long-term process. Nevertheless, Danish biotech and pharma companies are still among the best in Europe when it comes to drug development and innovation. However, Dr Rasmus Beedholm-Ebsen at Invest in Denmark argues it is important to look into new methods in order to discover and develop new drugs, and to have an innovative approach when it comes to drug delivery. ...

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