Since starting these postings we’ve had a lot of questions about some of the basics of drug safety.  So our thought is that this would be a good time to review what you need to have and what is nice to have to do drug safety and pharmacovigilance (PV). So here is a review of…

We are continuing and finishing 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) available at: https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM236905.pdf We are now going to examine the FDA reviewer’s handling of AEs.  As in the previous parts of this review, all…

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 have covered the introductory sections and now are looking at the methodology and other sections.  As in the previous part of this review, all sentences…

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 & Procedures (MOPPs) of CDER. Although some are as routine and mundane as anyone else’s SOPs a few are gems and are well worth reading…

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 patients possible particularly before launch and particularly before the drug is on the market and bringing in money from sales. Ask the Statistician (numbers do…

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 requirements for the submission of post-approval (post-authorization) aggregate reports. Why do I need to know this?: If your company, partner, vendor, client etc. handles adverse…

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 public consultation from June 27 to August 24. It describes how the EU and member states (MS)will do drug safety/PV inspections. Why do I need…