FDA Featured Articles

  1. 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. 

  2. 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?

  3. 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?

  4. 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?

  5. 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.

  6. 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.

  7. Challenges In Managing Life Science Regulatory Submissions & Correspondence 10/17/2014

    Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.

    Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.

  8. 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.”

  9. Industry Insights From The Executive Director Of Compliance At Seattle Genetics 8/1/2014

    Kristin Rand always had a fascination with questions science had not yet answered, and she developed an interest in genetics while still in high school. She obtained an undergraduate degree in the Diagnostic Genetic Sciences program at UCONN. FDA law and bioethics were the focus of her graduate degree in law, and she later earned a master degree in industrial-organizational psychology.

    After serving in various positions at Wyeth and Genentech, she landed at Seattle Genetics, where she currently serves as executive director of compliance. In this piece she discusses trends in pharma compliance, and challenges companies can expect to face in 2014 and beyond.

  10. Analytical QbD at Teva: Knowledge Is Power Only When You Share It 7/3/2014

    Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.