FDA’s Internal SOP On How To Do An NDA Safety Review Part 2

Bart Cobert / Sep 26, 2012

We are continuing the review of one of the FDA’s critical internal SOPs: MOPP 6010.3R: Attachment B: Clinical Safety Review of an NDA or BLA (Issued 12/14/2010; Posted 12/14/2010). We[…]

The FDA’s Internal SOP On How To Do An NDA Safety Review Part 1

Bart Cobert / Sep 18, 2012

One of the lesser known aspects of the FDA is that their SOPs are in the public domain and are available on-line. They are found in the Manual of Policies[…]

What Is The Right Size For A Safety Database?

Bart Cobert / Sep 10, 2012

An often asked question. The answer depends on whom you ask. Ask the Chief Financial Officer (money does matter of course) and the likely answer is the smallest number of[…]

The Wave – EMA’s New PSUR-PBRER

Bart Cobert / Aug 30, 2012

What is this about?: The EMA has released (June 2012) the new “Guideline on Good Pharmacovigilance Practices (GVP) – Module VII – Periodic Safety Update Reports” which covers the new[…]

New EU Draft Guideline on Pharmacovigilance Inspections “We are here to help you…”

Bart Cobert / Aug 06, 2012

What is this about?: In late June 2012 the EMA released its “Module III” on PV inspections. This is a draft guideline due to be finalized by year end with[…]