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Regulations in cases such as pandemics

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Wonbum Sohn
Posts: 37
Eminent Member
Topic starter

In the case of diseases that has a global pandemic like COVID-19, I have seen simplified regulations to produce products rapidly.

In this case, I am wondering what kind of change there is in the initiating and planning phase of project management.

Also, if the pandemic is over, will these companies have to go through the previous regular regulations?

Posted : 30/04/2022 8:27 pm
Posts: 50
Trusted Member

The COVID-19 vaccinations received emergency use authorization which is the FDA's way of expediting its availability during a public health emergency, when no alternatives exist, and when the benefits outweigh the potential risks based on interim or final phase 3 clinical trial data. Nevertheless, the FDA had to ensure safety and efficacy first before granting authorization. The FDA continues to regulate products even after they receive approval. In the case of products which receive emergency use authorization, that authorization can be changed or revoked but only lasts for as long as the public health emergency. The companies then pursue full FDA approval - as was the case with the Pfizer and Moderna vaccine as well as the use of Remdesivir. 

Posted : 01/05/2022 1:59 am
Posts: 37
Eminent Member

In the case of the initiating and planning stages I am sure the changes are not drastic other than the timeline being much tighter than it would be normally for products that are meant to aid in the pandemic. As mmodi mentioned above emergency approval had to be granted to the vaccines to push them through as fast as they did. However, I do not think this will be a thing that continues after the pandemic as there is already a framework in place for going back to the old system after the pandemic. The only thing that might happen is people claiming these products that received emergency approval as substantially similar to a product that they are trying to get approved however as mmodi had said many many of these products are pursuing full FDA approval once the emergency approval runs out so ther should be no risk of this. 

Posted : 01/05/2022 10:12 am
Posts: 79
Trusted Member

It is interesting how the pandemic has simplified regulations. I agree with the above posts that believe the regulations will go back to the original framework once the pandemic is fully over. Due to the recent political situation in Ukraine, regulations on medical devices have essentially been lifted to help support the population there. However, the simplified regulations are only in affect for the duration of the martial law. Although it is a completely different situation, I think the premise is similar and the regulations will go back to the original framework.

Posted : 02/05/2022 12:02 am
Posts: 75
Trusted Member

Being working in the pharmaceutical sector and working on the development of the COVID Vaccine, I could tell that the initiating and planning phase that we experienced was not all that different from what would be done otherwise. All practices or qualifying an assay and rigorous testing and methods of data collection were all in place and those key development of the scientific theory was not ignored or cut corners. All that was changed in the field was the timeline and the financial liberty we were allowed. Oftentimes, in pharmaceuticals, the biggest time consumption is the human factor in that people have days off and have other prior commitments. During the pandemic, we saw points where individuals had to come in on weekends and work regular shifts, albeit being paid accordingly. And other means necessary to meet the tighter deadline. However now, when we have other projects, the original timelines that usually are set are back in place and the rigorous testing and regulations are back in action. 

Posted : 02/05/2022 12:30 am