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
Just before Christmas, FDA issues several Warning Letters to manufacturers of CBD products for making drug like claims. These included products intended for risky route of administration such as nasal, ophthalmic and inhalation. All the products for which Warning Letters were issued technically sold CBD products as dietary supplements or food, while making claims to … Read more
In the first Guidance Document of 2021, FDA emphasized a very important procedural aspect of sponsor-FDA meetings arising from the sponsor inviting outside parties to such meetings. FDA warns that bringing an outside party to a sponsor-FDA meeting could potentially compromise the confidentiality of the information discussed at the meeting unless the sponsor took legal … Read more
