Regulatory

  1. Are You Prepared For The Upcoming USP <800> Requirements?
    3/15/2017

    The United States Pharmacopeial Convention (USP) has developed a chapter on hazardous drug (HD) handling in healthcare, USP <800>, which will become effective on July 1, 2018. For facilities that handle hazardous drugs, there’s no time to waste in working toward compliance, because facility design/redesign and construction may be necessary to achieve it.  USP chapters numbered less than <1000> are requirements, not guidelines, in the United States, so compliance is necessary.

  2. Examining FDA’s New Quality Agreement Guidance
    3/10/2017

    The new FDA guidance is a simple one, providing best practices and high-level insight into the components of a quality agreement. This article continues the discussion from Part 1, analyzing the elements that the agency indicates should be included in quality agreements — and explaining how FDA missed a chance to truly provide value to the industry.

  3. Pharma Field Trips: Is Hosting The FDA A Good Idea?
    3/8/2017

    Inviting FDA scientists into your manufacturing facility or laboratory for one or two days may feel unsettling, but it can be rewarding when the visits are designed to bring FDA scientists up to speed on real-world issues and new technologies.

  4. Pharmaceuticals Escape The Knife As GOP Mulls Medicaid Reform
    3/1/2017

    After bracing for the worst, pharmaceutical executives emerged from a White House meeting with newly installed President Donald J. Trump relatively unscathed. But they soon concluded that his ever-roving spotlight would be back on them in a matter of time.

  5. Pharma Off-Label, On-Label, And Free Speech
    2/27/2017

    The FDA gives manufacturers additional guidance for scientific communications, but is it much ado about a little?

  6. 5 Important Takeaways From The FDA's Revised Quality Metrics Guidance
    2/23/2017

    On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents and what pharma manufacturers and CMOs should take away from these changes.

  7. Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances
    2/15/2017

    Over the past 10 years, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued new and revised regulations and guidances in an attempt to define, clarify, and modernize their requirements.

  8. FDA’s New Quality Agreement Guidance — What It Says (And What It Fails To Say)
    2/1/2017

    In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.

  9. What To Know About Post-Grant Review And The Biotech Industry
    2/1/2017

    Patent litigation can often be a costly, lengthy, and resource-intensive endeavor. Recognizing the frequency, duration, and potentially debilitating effects of patent litigation, Congress passed the America Invents Act (AIA) in 2011.

  10. Brexit Presents Opportunity For U.S. Life Sciences Companies
    2/1/2017

    The United Kingdom’s decision to leave the European Union (E.U.) in June 2016 sent economic shockwaves throughout international markets. While Britain is taking time to understand the impact of adopting Article 50 of the Treaty of Lisbon, which will trigger its exit from the E.U. (the so-called “Brexit”), U.S.-based companies may have a unique opportunity to expand and take advantage of operations in the U.K.