Regulatory

  1. 2019 U.S. State Policy Trends Impacting Pharma Manufacturers
    7/31/2019

    If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.

  2. How To Prepare For An FDA Inspection
    7/29/2019

    An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections and will generally result in inspectional observations.

  3. 3 Surefire Approaches To SOP Harmonization
    7/25/2019

    We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

  4. Understanding The FDA’s Breakthrough Devices Program
    7/8/2019

    Well-prepared manufacturers can benefit from close collaboration with the FDA during the intensive approval process, propelling their products to market in a relatively short period of time.

  5. New FDA Guidance On Biosimilar Interchangeability
    7/3/2019

    A summary of the FDA’s recent guidance titled “Considerations in Demonstrating Interchangeability with a Reference Product” regarding biosimilars.

  6. An Analysis Of 2018 FDA Warning Letters Citing Data Integrity Failures
    6/12/2019

    FDA enforcement for failures in data integrity and data governance began almost 20 years ago, and these areas remain as enforcement initiatives of the FDA and other global health authorities to this day.

  7. Medicare Negotiation And Competitive Licensing Act: An Ambitious Challenge To Biologic Patents
    5/21/2019

    In recent years there has been growing, bipartisan support to address the perceived high cost of biologic drugs. Indeed, recent estimates are that biologic drugs account for approximately 40 percent of all U.S. pharmaceutical sales and 70 percent of drug spending growth between 2010 and 2015.

  8. A High-Level Overview of the Proposed Rule To Align FDA’s QSR with ISO 13485
    5/13/2019

    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.

  9. How The Purple Book Continuity Act Could Challenge Biosimilars & The FDA
    5/7/2019

    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.

  10. Understanding The FDA’s Final Guidance On Manufacturing Site Changes
    4/22/2019

    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.