REGULATORY ARTICLES

  • Persistent Noncompliance Leads To A Consent Decree

    What happens when failures are discovered repeatedly during FDA inspections, even after the company has been warned to correct them?

  • The Modernization Of Life Sciences RIM

    A decade since we started tracking their ambitions for improving global regulatory information management (RIM), life science regulatory operations have achieved much in modernizing the immediate function globally and improving general operational efficiency.

  • 5 Steps To Eliminate Weak Links In Your Data Governance

    Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.

  • FDA Releases Guidance On Drug Products Containing Nanomaterials

    In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.

  • Frequent Deficiencies In GMP Inspections, Part 1

    It is sometimes astonishing how often pharmas and biotechs "commit" similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.

  • Survey Reveals High Levels Of CTIS Adoption In Europe

    Early feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life science leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been strong.

  • Key Insights From The 2022 PDA/FDA Joint Regulatory Conference

    Key focus of this article is spent on thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.

  • 5 Specifications That The FDA's Diversity Plan Needs To Include

    The FDA’s recommendations provide a much-needed action plan to jumpstart the changes that need to be made to ensure inclusive care, yet these recommended guidelines only scratch the surface of ideal action in clinical trials.

  • FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics

    The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.

  • Tips For Your Virtual Meetings With The FDA

    It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.