REGULATORY ARTICLES

  • A High-Level Overview of the Proposed Rule To Align FDA’s QSR with ISO 13485
    A High-Level Overview of the Proposed Rule To Align FDA’s QSR with ISO 13485

    The latest version of ISO 13485 already contains several requirements that do not exist in 21 CFR 820. In advance of the new proposed rule’s release, this article presents a summary of the potential changes’ impacts on medical device manufacturers once the proposed rule becomes final.

  • How The Purple Book Continuity Act Could Challenge Biosimilars & The FDA
    How The Purple Book Continuity Act Could Challenge Biosimilars & The FDA

    On March 5, 2019, Representative Anna Eshoo (D-CA) introduced H.R. 1520, the “Purple Book Continuity Act of 2019.” The bill addresses the availability of information about approved biological products that may support the development of biosimilar products. It has five cosponsors in the House, drawn from both sides of the aisle, and was considered with five other bills by the House Energy and Commerce Committee on April 3, 2019. The Committee advanced the bill, along with five others, as a step toward addressing runaway drug pricing.

  • Understanding The FDA’s Final Guidance On Manufacturing Site Changes
    Understanding The FDA’s Final Guidance On Manufacturing Site Changes

    The guidance looks at what constitutes a manufacturing site change, when a manufacturer should submit a PMA supplement, what documentation should be submitted to the FDA with a site change supplement, and more.

  • Inside FDA's Proposed Program To Establish Voluntary Quality Standards
    Inside FDA's Proposed Program To Establish Voluntary Quality Standards

    The FDA’s CDER recently released draft guidance aimed at the development and recognition of voluntary consensus standards for pharmaceutical quality.

  • How Will USPTO Guidance Revisions Impact Biosimilars?
    How Will USPTO Guidance Revisions Impact Biosimilars?

    Since 2012, patent stakeholders in the U.S. have faced remarkable uncertainty in the evaluation of patent subject matter eligibility under 35 U.S.C. 101, particularly in the application of the Supreme Court’s Alice/Mayo1 test by the United States Patent and Trademark Office (USPTO). 

  • Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb’s Exit
    Raising The Bar: The Silver Lining Of FDA Commissioner Gottlieb’s Exit

    It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23rd Commissioner of the FDA, announced his decision to step down after 663 days (22 months) on the job. The news is sure to raise concerns for many. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.

  • Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis
    Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis

    When SMEs, management, and others gather to perform a risk assessment or a root cause analysis on a failure, they’re sure to achieve the desired outcome, right? Perhaps for a simple risk assessment or investigation, but success is not very likely for one that is even moderately complicated. That’s where a skilled facilitator is needed.

  • Why Data Integrity Is Impossible Without A Quality Culture
    Why Data Integrity Is Impossible Without A Quality Culture

    For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”

  • How To Write An Effective Validation Master Plan
    How To Write An Effective Validation Master Plan

    A validation master plan outlines the principles involved in the qualification of a facility, defining the areas to be validated, and provides a written program for achieving and maintaining a qualified facility.

  • An Analysis Of FDA FY2018 Drug GMP Warning Letters
    An Analysis Of FDA FY2018 Drug GMP Warning Letters

    This article presents a detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements. This allows manufacturers and sponsors to identify new trends in the focus of FDA inspectors and to act to address or justify similar situations at their own firms.

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