REGULATORY ARTICLES

  • Facilitating Great Virtual Meetings During A Pandemic (Or Any Other Time)

    Even before the global pandemic of the novel coronavirus, virtual meetings were on the rise, With a large percentage of people working from home, it's now a public health imperative. Here's how to facilitate a risk assessment, root cause investigation, or something similar via “virtual facilitation” with team members and subject matter experts scattered around the world.

  • Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits

    While we have not seen any significant delays in regulatory approval of life science products to date, the impact of COVID-19 on regulatory interactions, inspections, audits, and global health authorities is continuing to evolve.

  • Understanding 2019 FDA Enforcement Trends — And What They Mean For 2020

    The FDA conducted a total of 18,034 inspections in FY2019, off which 6,434 were inspections of biologics, medical device, or drug companies. Those inspections resulted in the issuance of 15,015 warning letters, a slight increase over 2018. The FDA also increased its import alerts, publishing 98 in 2019. This corresponded with a decrease in injunctions and seizures, showing the FDA’s preference for earlier preventive measures over later involvement.

  • Analyzing FDA's Final Q&A Guidance On Transition Biologics

    For 10 years, the date March 23, 2020 was circled in red on the FDA calendar. On that “transition date,” certain drugs FDA approved under the drug approval statute were “deemed” to have a biologics license instead of a New Drug Application approval. How soon will biosimilars see an impact?

  • Harmonization Horrors: When Quality System Alignment Goes Wrong

    This article is the first in a two-part series explaining how to successfully harmonize disparate quality systems when two companies merge. Here in Part 1, we will focus on what not to do when reconciling two quality systems, providing real-life examples — drawn from the author’s experiences — from each phase of QMS harmonization.

  • FDA FY2019 Warning Letters: A Closer Look At Drug Manufacturers

    Part two of this series takes a deep dive into the types of drug manufacturers that received warning letters and their locations, including data on how frequently the FDA recommends that firms hire qualified consultants and its request for “independent assessments” in warning letters.
     

  • The Future Of Life Sciences Regulation: Adapt Or Die

    Like machine learning and artificial intelligence, cell and gene therapy solutions present a challenge (particularly for sponsors and regulators) in that the interpretability and explainability of results are challenging.

  • 3 CMC Mistakes That Could Cost You Billions

    The end game for many small biotech startups is acquisition by Big Pharma. While CMC may not add zeros to the sales price, poorly documented development can remove them. These three due diligence keys can help preserve your company valuation.

  • U.S. Sites Play Surprise Role In FDA’s Drug GMP Warning Letter Report

    Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.

  • An Analysis Of FDA’s Recently Issued Gene Therapy Guidances

    In this article, we'll examine key changes to FDA's six finalized draft guidance documents on its framework to advance gene therapy. We'll also review a new draft guidance on determining “sameness” of gene therapy products for orphan drug designation/exclusivity.