Last week the US FDA Center for Drug Evaluation and Research (CDER) published an update to their guidance agenda for calendar 2016. Originally published in January, this is the mid-year update, when the CDER has a shorter window to think about and, presumably, can be more accurate. What has changed since January? The number of Drug Supply Chain Security Act (DSCSA)-related draft guidance they expect to publish by year end remains the same, as reported by our friends at the Regulatory Affairs Professionals Society (RAPS).
In fact, according to RAPS, those same six draft guidances were Continue reading FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected
Last week I listened in on a 
Everyone who markets drugs in China has been watching for the publication of revised requirements for tracing drugs there since 
It is a little surprising that the 
This week I am posting one of my favorite essays from last fall because at this moment, I am in the middle of moving my home and office from one side of the Chicago metro area to the other to be closer to our kids. Also at this moment, the FDA is almost eight months late in publishing the grandfathering guidance that was mandated by the DSCSA. Here it is again.
Don’t worry. It is not my intention to change this pharma/regulatory/technology blog into a political platform, but after the events of last week, I think it is appropriate for all of us to step back and examine how we can make our country better. I believe I can make a positive contribution by explaining my sincere interpretation of #BlackLivesMatter. I first heard the phrase “Black Lives Matter” back in 2012 when 
A revolution occurred last week. Not by guns—