REGULATORY ARTICLES

  • Examining FDA’s New Patient Labeling Draft Guidance
    Examining FDA’s New Patient Labeling Draft Guidance

    In accordance with the increasing emphasis on human factors as it applies to medical products and their associated written materials, the FDA recently released the draft guidance document Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format. Instructions for use (IFU) are a critical element of the device user interface, and special considerations must be accounted for in their design.

  • FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018
    FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018

    In this two-part article, FDA Supervisory Consumer Safety Officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 Program Director Art Czabaniuk, and OPQO Division 3 Investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. Part 1 unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.

  • Decoding FDA’s Refuse To Receive (RTR) Standards For ANDA Submissions
    Decoding FDA’s Refuse To Receive (RTR) Standards For ANDA Submissions

    Though the FDA has laid down clear steps for abbreviated new drug application (ANDA) submissions, applicants still struggle with the procedural challenges in preparing and submitting their applications. As such, it is important to dig deeper into the process and understand the possible reasons why the FDA may refuse to approve — or even refuse to receive (RTR) — an ANDA submission.

  • 2019 U.S. State Policy Trends Impacting Pharma Manufacturers
    2019 U.S. State Policy Trends Impacting Pharma Manufacturers

    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.

  • How To Prepare For An FDA Inspection
    How To Prepare For An FDA Inspection

    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.

  • 3 Surefire Approaches To SOP Harmonization
    3 Surefire Approaches To SOP Harmonization

    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?

  • Understanding The FDA’s Breakthrough Devices Program
    Understanding The FDA’s Breakthrough Devices Program

    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.

  • New FDA Guidance On Biosimilar Interchangeability
    New FDA Guidance On Biosimilar Interchangeability

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

  • An Analysis Of 2018 FDA Warning Letters Citing Data Integrity Failures
    An Analysis Of 2018 FDA Warning Letters Citing Data Integrity Failures

    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.

  • Medicare Negotiation And Competitive Licensing Act: An Ambitious Challenge To Biologic Patents
    Medicare Negotiation And Competitive Licensing Act: An Ambitious Challenge To Biologic Patents

    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.

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