iwewlkws 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
It seems like stating the obvious, but the pandemic will have some long-term negative effects on the FDA-regulated industry at least for the next few years which would tangibly and perceptively affect new product development and healthcare. Here we list five that seem most obvious to us. First, there is a huge backlog of clinical … Read more
As the year of the worst pandemic in modern times comes to an end, it is time to reflect on five major changes in drug development and healthcare, that are here to stay for good. To be fair these are less of changes and more of appreciation of what existed before but was used less … Read more
Proprietary names of drugs and biologics are valuable for building the brand recognition and medication preferences of doctors and patients alike. To emphasize the importance of appropriate proprietary names, also called Brand names, of both prescription and non-prescription drugs and biologics, FDA this week released two Guidance Documents to describe the expected practices for drug … Read more
