LSL Web-Exclusive Content

  1. A Prescription For Change: Navigating Tax Reform In 2017

    Proposed changes to the tax code could have a pervasive impact on Pharma’s business strategy.

  2. Preparing For IDMP Compliance – What You Need to Know

    Beginning in early 2017, life sciences organizations that intend to manufacture and/or market medicinal products within the European Union will be required to comply with the Identification of Medicinal Products (IDMP) regulations, a global framework for identifying medicinal products, set forth by the European Medicines Agency (EMA).

  3. Trump/GOP Plans For Obamacare, Medicare, & Medicaid Have Far-Reaching Pharma Effects

    An ideology-driven rush to undo decades of healthcare policy — and the uncertainty this will create — presents real hazards for every segment of the U.S. healthcare system, including the pharmaceutical industry.

  4. 21st Century Cures & FDA Implementation: 5 Important Takeaways For Biopharma Companies

    Now that the 21st Century Cures bill has been signed into law — following a nearly three- year journey that included a fair number of detours and roadblocks — all eyes in the drug development world are shifting to FDA.  To the question “What now?”  FDA can answer: A great deal of work.

  5. The Winners & Losers Of The 21st Century Cures Act: Patients

    On December 13, 2016, President Barack Obama signed into law the 21st Century Cures Act, which passed both houses of Congress in a rare showcase of bipartisan unity. With such broad support, it would seem that the law must be a win-win for all. But is it? As we delve deeper into what the law means for healthcare in 2017 and beyond, more information is coming to light about the real winners and losers affected by the Act. And there’s one group that stands to both win and lose the most: patients.

  6. Insights On FDA: What We Can Learn From Two New U.S. Inspector General Reports

    The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) recently released two reports that contain nuggets of interest to those who are watching for trends in the pharmaceutical industry.

  7. Merck’s Path To Continuous Manufacturing For Solid Oral Dose Products: What Stands In The Way?

    As the evolution of the global pharmaceutical industry continues to drive the need for more flexibility and lower costs, continuous manufacturing becomes an even more appealing and sensible option. However, despite the tremendous promise of its economic and quality control benefits, there are still many concerns about the regulatory landscape for continuous manufacturing. Dr. Christine Moore, executive director and global head of chemistry, manufacturing and control (CMC) policy at Merck, recently discussed the company’s pursuit of worldwide approval of continuous manufacturing for solid oral dosage products and what regulatory risks it sees as potential roadblocks.

  8. Resisting Fragmentation In The Global Serialization Regulatory Landscape

    In 2013, the United States enacted pharmaceutical serialization and traceability requirements under the Drug Supply Chain Security Act (DSCSA). In the years preceding and following passage of the DSCSA, many other countries considered similar regulation for their own markets. Argentina, China, India, South Korea, and Turkey currently require the serialization of pharmaceutical products and the reporting of some type of serialization data. Approximately 40 additional countries — including the U.S., the European Union, Brazil, Russia, and multiple Persian Gulf states — have enacted requirements with future implementation dates or are actively working on requirements.

  9. 5 Steps To Help Keep Liability In Check During Clinical Trials

    There is perhaps no riskier time in a product’s development cycle than during clinical trials. With the introduction of human research subjects, patient safety is paramount. Any failure to uphold rigorous standards not only leaves your company subject to the threat of costly litigation, it can cause irreparable damage to your reputation.

  10. Managing Global Healthcare Professional Entertainment Limits

    In the life sciences industry, a company’s anticorruption policy inevitably governs how employees engage with foreign healthcare professionals (HCPs) – who are considered foreign government officials (FGOs) under most global anticorruption laws.