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Approval Programs News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Crickets, Pot, and Pigs! Oh My! A View of 2022…

There has never been a time in history with as much going on in food safety and food law. Scott Haskell lists over 20 issues that industry and regulators need to look out for in 2022. How many of these directly relate to your organization?

The case for creating excess capacity at the US Food and Drug Administration

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 their review, they may end up approving a drug without adequately understanding its efficacy and safety, leaving room for unforeseen side-effects. These include safety issues around the drug itself, along with treatment dangers such as unsafe dosages and failing to highlight potentially dangerous drug interactions. Yet if regulators endeavour to understand all possible scenarios, it may take an

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