Nitrosamines – Expensive Witch Hunt or Very Broad Safety Concern?

I have recently touched upon the subject of nitrosamines in drug products as part of a blog on Extraneous Peaks. (here)  The concern about nitrosamines in drug products continues to grow, and it will be a significant challenge for the regulators and pharmaceutical industry to establish meaningful policies and procedures to ensure there are no safety concerns for marketed products. 

Doctor holding a clipboard with Safety first, Medical concept

Postmarketing Study Reveals Higher Risk of Blood Clots and Death – FDA Approves Boxed Warning

Like many drugs that undergo clinical trials (even larger trials), rare adverse events may not become apparent until well after the drug is in wider use after approval.  In addition, as a condition of approval, the FDA often requires a post-approval commitment to further study the drug.  Such is the case as described in the updated Safety Communication released today by the Agency as FDA announced it approved “a Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz,

New FDA Guidance Released on Live Case Presentations for IDE Clinical Trials

We are living in a world that is constantly changing and using forms of media such as videos and live recordings as forms of communication, notification, training and archiving of special events.  In this age, we are constantly bombarded with Tweets, G-Chats and Facebook posts that have videos attached.  We can stream tv shows, live news reporting and sports events in real time.  

New MaPP Fully Outlines Process for FDA Safety Label Changes

New MaPP (Manual of Policy and Procedures) 6004.3 (here) fully outlines the internal process that FDA will go through for reviewing and recommending safety label changes (SLCs) for NDAs, BLAs, and ANDAs.  It also discusses the process for FDA-mandated and -ordered label changes “when implementing section 505(o)(4) of the Federal Food,