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
