Happy Thanksgiving
Hello all who read this blog! We will be taking a few days off to celebrate the Thanksgiving Holiday here in the US. We hope you all...
The Role of Regulatory in Safety
This is one of those that generally varies from company to company, but one thing that is important to remember is that Regulatory *does*...
WHO and Zika
According to the World Health Organization (WHO), the Zika virus is no longer an international public health emergency. This will not...
Opioids - Where are we now?
Back in 2009, the FDA began meeting with companies regarding Long-Acting/Extended Release Opioids. The purpose of these meetings was to...
Study information on celecobix
According to a new study published in the New England Journal of Medicine, celecobix (Celebrex) is as safe as, and "may even be safer...
PDUFA VI - Some thoughts
At the end of 2017, PDUFA V expires, so the FDA is currently looking at options in PDUFA VI. It will be vital to understand these...
Orphan Indications
"The three most important things for companies tackling rare diseases to get right are regulatory affairs, regulatory affairs, and...
EMA Webinar for Type 1 Variations
Copied from the EMA Website: The European Medicines Agency (EMA) is organising a webinar on 15 November 2016 to advise stakeholders on...
Partnership with African CRO
It is with great pleasure that I can announce that Lessem Regulatory Consulting Group, LLC has entered into a partnership with LT...
Thoughts on the FDA
This past Veterans Day, the US Food and Drug Administration posted a blog on the race to get penicillin to soldiers in WWI. This made me...
