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How To Navigate Clinical Data Per EU MDR By Matthias Fink, MD, TÜV SÜD America In May 2017, the European Medical Devices Regulation (MDR) 2017/745 was published to replace the current Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). In April 2020, the European Parliament adopted the European Commission’s proposal to postpone the Date of Application (DoA) of the MDR by one year, and as such, the new DoA is May 26, 2021. It is worth noting that the end of the transition period for MDD and AIMDD certificates remains May 26, 2024, thus reducing the t...

Jeffrey Clemens, Parker Rogers The public and political pressure on vaccine developers and global regulatory approval agencies has never been higher. The world has been eagerly awaiting any – and all – developments regarding vaccines and therapeutics required to fight the current Covid-19 pandemic. While the demand side is willing to pay almost any price for an effective and fast solution, unfortunately neither the drug development nor the drug approval process is designed to deliver speed and safety free of trade-offs.  The dilemma faced by the regulators is simple. If regulators rush t...

Usually titled “52 Places to Go” and compiled by recommendations from editors, reporters, and contributors at the New York Times, the annual story switched it up this year by publishing reader recommendations “that have delighted, inspired, and comforted them in a dark year.” From more than 2,000 recommendations, the publication included 52 destinations, including Andros, the northernmost island of the Cyclades archipelago. The reader who submitted the Andros piece, Maria Dal Pan, wrote, “Hospitality is in the heart of the island as Andros has not ceased to maintain its authenticity...

At this time of year, The New York Times’ Travel desk usually publishes its lavish 52 Places to Go list, a compendium of suggestions for the destinations that are especially worth visiting in the coming year, accompanied by show-stopping photography. But in this pandemic year, creating our usual list was out of the question.