iwewlkws Vaccines have overwhelmingly dominated the public and regulatory attention since the beginning of the pandemic. Most of the public funding and resources seems to have been devoted to developing effective vaccines rather than therapies. And it has worked, for the vaccines. While we have several vaccines for Covid and billions of people worldwide have been … Read more
Just like human drugs, animal drugs can also be approved based on real world evidence available from veterinary records. However, there are several issues to be considered for creating sufficient supportive real world data for animal drug approval applications. A new FDA guidance released this week discusses the nuances of the real world data (RWD) … Read more
The rapid increase in digital medicine products is leading to flawed products that could hurt patients using them, according to a report from the Brookings Institute this week. The report states that the core technology behind such products, “affective computing” or “emotionally intelligent computing”, remains in its infancy and is being introduced improperly “without scientific … Read more
Clinical trials conducted to support market approval of new drugs must follow a quality by design (QbD) approach where each clinical study, included in the market approval application, identifies factors that were critical to the quality of the study and how those risks were managed during study conduct. A new guidance from ICH released this … Read more
Pharmacies located within hospitals are not required to register with the FDA as “Outsourcing Facilities” and are exempt from following GMP. However, there are strict conditions for the compounding operations performed at such hospital pharmacies some of which needed clarification and relaxation. This week, FDA did just that by relaxing the rules ever so slightly … Read more
When FDA, industry, or any other stakeholder (collectively called the “messengers”) become aware of any cybersecurity vulnerabilities in a medical device connected to the internet, they must inform the patients and caregivers (collectively called the “users”) in an easy to find, read and understand communication on the internet, social media, or television. This is explained … Read more
This week FDA published the final rule for the De Novo classification request for novel medical devices keeping the process mostly same as the previous rule. The process still requires that the applicant submit a detailed De Novo Class I or II designation request after the 510k application has been rejected or no predicate exists, … Read more
A new draft FDA guidance released this week describes all the factors that govern FDA’s decisions about market approval of new drugs and biologics, and it is apparent that the benefit-risk assessment of new products is far from black and white, but various shades of gray. The guidance appears more like an opinion article than … Read more
The 510k applications are one of the very few regulatory applications that are still submitted as fully or partially paper documents that must be mailed to the FDA offices rather than uploaded to the Electronic Submission Gateway (ESG). This week FDA released a guidance describing its process to transition to electronic 510k applications. The process … Read more
An old ethical question about should a sponsor pay or not pay subjects for participating in their clinical trials was investigated in two clinical trials, one with high risk to subjects and another with low risk to subjects. It was found that for the study where subjects would have low risk to participate, the financial … Read more
