REGULATORY ARTICLES

  • Impact Of International Trade Regulations
    Impact Of International Trade Regulations

    The significant number of national and international trade regulations are challenging for the development of logistics strategies for global clinical research. Identifying the similarities, differences and obstacles pharmaceutical companies face while importing and exporting medicinal products for clinical trials creates an opportunity to streamline the process, remove barriers, and improve efficiency.

  •  Trump’s Deregulatory Agenda:  What It Could Mean For Biopharma & Medtech Companies
    Trump’s Deregulatory Agenda: What It Could Mean For Biopharma & Medtech Companies

    President Trump promised to take action to streamline the federal government. Within just a few days of taking office, he launched his deregulatory agenda, and he has now issued several executive orders that build on each other. How the concept will be implemented and by whom will continue to evolve with the addition of key staff.

  • An FDA Perspective On Patient Diversity In Clinical Trials
    An FDA Perspective On Patient Diversity In Clinical Trials

    Since the late nineteenth century, it has been well-known that individuals can vary widely in their responses to the same medication. Yet, accurately predicting and addressing the effects of that variability during drug development has continued to bedevil researchers, drug sponsors, and regulators.

  • USP Keeps Pharmaceutical Quality In Focus
    USP Keeps Pharmaceutical Quality In Focus

    Fueled by its nearly 200-year history, the USP is taking a new look at the value and execution of pharmaceutical quality

  • FDA's Quality Metrics Guidance: Reading Between The Lines
    FDA's Quality Metrics Guidance: Reading Between The Lines

    A previous article covered several key things the FDA's Revised Quality Metrics Guidance document did communicate to industry, Lou Angelucci, currently a project management consultant to Johnson & Johnson, focuses more on what the guidance document failed to say and do … and the implications of those omissions.

  • Interacting With The FDA — Best Practices For Drug Development Success
    Interacting With The FDA — Best Practices For Drug Development Success

    When it comes to dealing with and interacting with the FDA, attitude plays an important part in ensuring the agency is on your side. How do you do this?

  • How To Ace Your FDA IND Submission (And How To Rebound If You Don’t)
    How To Ace Your FDA IND Submission (And How To Rebound If You Don’t)

    Let's assume you have your pre-IND ducks in a row. Now you're ready to embark on preparing and submitting the IND application to the FDA, which, if approved, will allow you to test your drug in humans for the first time. 

  • Are You Prepared For The Upcoming USP <800> Requirements?
    Are You Prepared For The Upcoming USP <800> Requirements?

    The United States Pharmacopeial Convention (USP) has developed a chapter on hazardous drug (HD) handling in healthcare, USP <800>, which will become effective on July 1, 2018. For facilities that handle hazardous drugs, there’s no time to waste in working toward compliance, because facility design/redesign and construction may be necessary to achieve it.

  • FDA's New Quality Agreement Guidance: What It Says (And What It Fails To Say)
    FDA's New Quality Agreement Guidance: What It Says (And What It Fails To Say)

    FDA’s new guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements specifically addresses seven elements that should be included in a quality agreement: quality unit activities, facilities and equipment, materials management, product-specific considerations, laboratory controls, documentation, and change control.

  • Pharma Field Trips: Is Hosting The FDA A Good Idea?
    Pharma Field Trips: Is Hosting The FDA A Good Idea?

    Inviting FDA scientists into your manufacturing facility or laboratory for one or two days may feel unsettling, but it can be rewarding when the visits are designed to bring FDA scientists up to speed on real-world issues and new technologies.

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