Featured Pharma Online Editorial

31. FDA's DSCSA Pilot Project Program — Should You Participate? 3/4/2019

    The FDA announced its intent to establish a pilot program to “share information, current practices, research, and ideas on the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the transaction information, transaction history, and transaction statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data.” The question for the industry is, should you participate in the pilot program?

32. Are You Prepared For The EU's Falsified Medicines Directive? 7/21/2016

    Given the complexities involved and time required for assessment and decision-making activities, it is imperative to start working toward meeting the EU’s Falsified Medicines Directive (FMD) standards immediately, leveraging previous efforts for compliance with other market regulations.

33. How To Streamline Serialization Implementations With Your CMOs 3/10/2016

    Managing CMO serialization implementation is a multifaceted process that requires thorough review and planning across functional teams to best understand all the components necessary for success. Thus, it is important for companies to recognize the barriers they will likely encounter during serialization implementation with CMOs — and plan accordingly.

34. Are There Business Benefits To Serialization Beyond Compliance? 6/18/2015

    This may seem a complex question to answer as you begin your serialization journey. It is difficult to look beyond the significant challenges that lie ahead in this undoubtedly complex project — initial funding and stakeholder engagement, vendor selection and delivery adherence, 

35. FDA And Industry Experts Offer Guidance For DQSA Preparation 3/3/2014

    It’s been over three months since President Obama signed the Drug Quality and Security Act (DQSA) into law, and some of the industry is still unsure how to proceed with preparation for Title II, which outlines the plan for supply chain security. In a recent discussion with Pharmaceutical Online, Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), encouraged the industry to familiarize itself with the law and the requirements under it.

36. Three Questions To Consider For DQSA Readiness

    By Dave Colombo and Dawn Wang, KPMG Life Sciences Advisory

    Last November, after much anticipation, the U.S. pharmaceutical industry saw the enactment of the Drug Quality and Security Act (DQSA), which includes in Title II the Drug Supply Chain Security Act (DSCSA). The DSCSA addresses national pharmaceutical track and trace requirements, and industry stakeholders must now prepare themselves for the first round of deadlines for lot-level traceability starting January 1, 2015. In preparation for these guidelines, it is important for companies to follow a framework as they assess their organizations’ readiness to meet DSCSA compliance. A successful program will do so by evaluating the impacts to their business processes and governance, technical solutions, and trading partner relationships.