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​Newsletter - January 14, 2021

Global Regulatory Dilemma Due to the Less Effective Chinese Vaccine

This week it was announced that the Chinese vaccine is only about 50% effective. That’s about half of the effectiveness of the Pfizer and Moderna vaccines but still above FDA’s threshold for authorization. This creates a unique circumstance for the regulators worldwide. Answers to three critical questions would influence....Read More
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Impact of Last Minute Rules for FDA and HHS by Trump Administration 

Last few weeks, the outgoing administration has been releasing several rules and policies governing FDA and HHS operations worrying industry and other stakeholders about their lasting impact. However, in most cases, it can be easily reversed by the incoming administration, as shown by the outgoing administration 4 years ago....Read More

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