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...
Pay-to-delay decision
This Tuesday it was announced that the US Supreme Court had declined to hear an appeal from the US Appeals Court which focused on the...
FDA Inspections - How not to do it
Looking through the FDA's website, the section on Warning Letters is always worthy of a brief read. This is where you can find out which...
eCTD Mandate at FDA
So what do you need to know for the upcoming mandate from the FDA to switch submissions to electronic? How long do you have to make the...
FDA updates Guidance on Race and Ethnicity Data Collection in Clinical Trials
On October 26, 2016, the US Food and Drug Administration issued an update to its Guidance on the collection of Race and Ethnicity Data as...
