FDA Featured Articles

11. 5 Mistakes To Avoid When Filing Your FDA Presubmission 12/22/2015

    This retrospective looks at common errors we've encountered in presubmission documents we've reviewed in the course of consulting engagements, and provides tips for avoiding those errors. 

12. What's Really To Blame For Drug Shortages? 6/15/2015

    Prescription drug shortages continue to plague the industry and endanger patients. Most experts suggest quality and manufacturing issues are the cause, but are other (more troubling) market dynamics at play?

13. Pharma's Quest For Consistent Quality 5/19/2015

    The preliminary findings from the International Society of Pharmaceutical Engineering’s (ISPE’s) Quality Metrics Pilot Program were revealed at the association’s recent Quality Metrics Summit. How will this data help the pharma industry create a universally accepted set of manufacturing quality standards and what challenges did the pilot uncover?

14. Is Pharma Ready For The Mounting Price Transparency Storm? 5/15/2015

    The pharmaceutical industry is under increased pressure to disclose cost and pricing information to justify the expense of prescription medications. What threat do these demands pose to drugmakers and how should the industry be prepared to respond?

15. Shifting Pharma's Mindset: Viewing Quality As Value Creator, Not Cost 5/14/2015

    The pharma industry is quickly, and fortunately, realizing that the value that quality creates can far outweigh the cost savings associated with not investing in it.

16. FDA Regs Help Secure The Global Supply Chain 10/27/2014

    A better strategy, coordination, and additional tools will help keep medicines and ingredients safe.

17. ISPE Set To Address Drug Shortages At Annual Meeting 10/6/2014

    Drug shortages continue to plague the pharmaceutical industry. According to a GAO report on shortages, dated February 2014, the number of shortages continues to increase in the U.S., as well as around the world. In 2007 there were 154 shortages, 114 new shortages and 40 ongoing from a prior year. In 2012, there were 456 shortages, 195 news ones and 261 ongoing. As of June 30, 2013, there were already 73 new shortages and 288 ongoing.

    The public health importance of these shortages cannot be overemphasized. Shortage situations have included zinc for parenteral nutrition in neonates and premature infants, doxorubicin for ovarian and other cancers, and Propofol for anesthesia.

    Clearly something needs to be done. “ISPE believes efforts to address this complex and multi-faceted problem of drug shortages requires close collaboration and clear communication between the pharma industry and global health authorities,” says Francois Sallans, VP and chief quality officer for Johnson & Johnson, and presenter at the 2014 ISPE-FDA CGMP Conference. “We believe The Drug Shortages Prevention Plan being assembled by ISPE will provide guidance to pharma and global health authorities to manage drug shortages more effectively. But more importantly we are looking into ways for the two groups to manage these shortages more proactively as well. That is an important component that we need to have in place in order to make these shortages rare, but short-lived.”

18. FDA's First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn't 6/23/2014

    On June 10^th, the long-awaited first draft guidance under the DSCSA was released by the FDA. For those holding high expectations that the guidance would offer specific direction on how to handle suspect/illegitimate products internally, you may come away feeling a little shortchanged. However, in the past, the FDA has come under scrutiny for using guidance to replace rule making, since this requires legislative involvement, so the lack of detail in the draft may be an effort to make room for flexibility that industry felt they weren’t getting before. Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action. I recently spoke with David Colombo and Dawn Wang with KPMG Life Sciences Advisory to find out what can be learned from this draft and where we go from here.

19. FDA Approval Pushes Novartis Into 21st Century Vaccine Development 6/18/2014

    In 2009, the world experienced a global threat in the form of H1N1. Despite a prompt response to the need for a vaccine in the United States, it was still not available until six months later and not enough doses were even produced to cover all Americans. During the year-long battle with the deadly virus, the CDC estimates between 8,870 and 18,300 people died due to H1N1-related complications. In the world of influenza vaccine production using chicken eggs, the response experienced during the H1N1 outbreak is not uncommon. Is this the best our industry can do? Novartis says NO.

20. Human Error Is The Leading Cause Of GMP Deviations – Or Is It? 5/1/2014

    Think of your company’s deviations. Concentrate on their most common root cause – the one you see most often and have the hardest time fixing. My high-tech-mind-reading-helmet tells me your answer is human error, correct? Magicians aren’t supposed to reveal their tricks, but this one really isn’t much of a trick.  Every company wrestles with human error.  We know humans have error rates – we’re not perfect.  But how many is too many?