Newsletter - May 13, 2021
“Why EUA, Why Not Approval?” EUAs Fuel Vaccine Hesitancy
Even though both Pfizer and Moderna Covid vaccines have been administered to almost 200 million people in the US and many more worldwide, some populations have hesitated to get vaccinated due to them being only authorized under EUAs and not formally “approved”. There are two sides of the story; on one side...Read More
You Can Go to Jail for Lying to the FDA (Just in Case, You Did Not Already Know)
Lying to FDA is a federal crime punishable by monetary penalties and jail time. We should never have to say that, but occasionally there are cases of people doing it anyway and becoming a warning for others. The case in point is of a team of clinical operations staff at a Florida CRO...Read More
“Why EUA, Why Not Approval?” EUAs Fuel Vaccine Hesitancy
Even though both Pfizer and Moderna Covid vaccines have been administered to almost 200 million people in the US and many more worldwide, some populations have hesitated to get vaccinated due to them being only authorized under EUAs and not formally “approved”. There are two sides of the story; on one side...Read More
You Can Go to Jail for Lying to the FDA (Just in Case, You Did Not Already Know)
Lying to FDA is a federal crime punishable by monetary penalties and jail time. We should never have to say that, but occasionally there are cases of people doing it anyway and becoming a warning for others. The case in point is of a team of clinical operations staff at a Florida CRO...Read More
