Prashant Kumar

It is no secret that FDA stopped all GMP inspections in March of last year due to the pandemic and then resumed highly curtailed risk-based prioritized domestic audits in the Fall. All through FDA used alternate ways to verify GMP compliance for US and foreign manufacturers. But the GAO does not believe it is acceptable … Read more

A review of Tweets from the winter season of 2019-2020 originating in Europe show that there was a jump in tweets about cases of pneumonia and unexplained illness across several European countries. Now we know that those were the early COVID-19 cases. Another review of social media messages originating around the same time in China … Read more

With two vaccines being used to rapidly vaccinate most Americans, it seems the other vaccines under development are either moving to other countries or getting out of this program. Many countries have eased approval of 2nd and 3rd tier vaccines to vaccinate their populations purely for financial and logistical reasons. How the world vaccinates its … Read more

Last year FDA approved the same number of new drugs as the previous two years demonstrating that the pandemic related disruptions did not affect the timelines for the new drug approvals. Also, like previous years more than half of the approved new drugs were intended for rare or orphan diseases and almost three-fourths (74%) of … Read more

With a new administration comes a general perception that it will bring major changes at the FDA. But new administrations do not affect most of the operations of the FDA, at least not immediately, and certainly not for most of the regulated industry. The most visible changes are at the administrative levels with a new … Read more

The oncology products and regenerative medicine products in development should see major positive changes with the new administration. The cancer moonshot that was announced near the end of the Obama administration, has not been in much news for the last 4 years. President Biden has a long history of championing cancer therapy development, and it … Read more

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. The Presidential election is not the … Read more

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 the regulatory outcome of the vaccines … Read more

A clinical investigator received a Warning Letter for not retaining the clinical trial records after the completion of the trial in a rare such letters issued by the FDA. This is an example of the systematic failure not only of the investigator but also the CRO and the sponsor who all share responsibility to maintain … Read more

A detailed histopathology is usually a critical part of a non-clinical toxicology study as it can indicate risk not obvious from observations of physical symptoms and could be used to evaluate long-term risk of an investigational product (IP). Often the study pathologist reviewing the data might need an independent assessment of abnormal findings to confirm … Read more