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
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
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
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
