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
Gut microbiome has been suggested to be linked to several diseases seemingly unrelated to the digestive system with the scientific literature rife with anecdotes and poorly designed studies. A report published this week provides a novel approach to establish microbiome-disease relationship that, in turn, could provide a scientific strategy to generate critical data for regulatory … Read more
With the news of two vaccines likely getting authorization in the next week or two, volunteers for other vaccine trials are getting scant. In a news this week, several volunteers in the control groups in other vaccine trials expressed interest to get the approved vaccines as soon as they become available. This could make completing … Read more
With UK approving the Pfizer Covid vaccine this week, there is increased pressure on FDA to be the next regulatory agency to do the same, which could be as early as next week. Historically, European and US regulators have routinely raced to be the first to approve well publicized new treatments. Covid vaccines fit that … Read more
