Katrina’s Blog™

Drug regulation is a global effort, with country specific agencies each with their own unique perspective on the regulatory challenges within their own borders. There is also an international group known as the ICH (International Council for Harmonisation of Technical...

The FDA publishes guidance documents to aid the medical products industry and the public in understanding and applying the regulations and requirements for pharmaceutical and medical device marketing approval. Supplemental information (in the form of Q&A guidance,...

The FDA has scheduled two public meetings, one in July and one in September, to obtain feedback related to medical device communications technologies. The first will be July 17th and is co-hosted by the Networking and Information Technology Research and Development...

Readers of this blog will recall my earlier posts (here and here) on expanded access programs which enable physicians of patients with critical and life-threatening conditions options to treat their patients with pre-approval medicines outside of a clinical trial...

Every year CDER publishes a list of the guidance it plans to create or revise during the year. This year’s list was published in early March and it contains a number of interesting topics. Some of these we have already discussed (like “Rare Diseases: Natural History...