REGULATORY ARTICLES

  • Brexit: The Good, The Bad, And The Chaos
    Brexit: The Good, The Bad, And The Chaos

    With just over half a year to go until the divorce date, and roughly two months until European Chief Brexit Negotiator Michel Barnier’s self-imposed October deadline for a Brexit deal, it has started to feel like we are finally seeing some concrete progress when it comes to Brexit.

  • Surveying The U.S. Regulatory Landscape For Cell And Gene Therapies
    Surveying The U.S. Regulatory Landscape For Cell And Gene Therapies

    The FDA has been issuing guidance documents addressing gene therapy development issues for approximately 20 years — a remarkable dedication of resources to an area that did not have a licensed product until 2017. Of the six gene therapy-related draft guidances the agency issued last month, two represent the first of the “suite of disease-specific guidance documents on the development of specific gene therapy products” Commissioner Scott Gottlieb promised in Dec. 2017. 

  • Gene Therapy For Rare Disease — Examining FDA's New Draft Guidance
    Gene Therapy For Rare Disease — Examining FDA's New Draft Guidance

    The FDA recently issued for public comment six draft guidance documents. This is the fourth article in a series and will discuss the guidance Human Gene Therapy for Rare Disease.

  • FDA And Quality Metrics: Where Do Things (Currently) Stand?
    FDA And Quality Metrics: Where Do Things (Currently) Stand?

    Are you ready to give the FDA more?  “What?” you ask, as a manufacturer of API and finished goods. Are you ready to give them more data and information about your manufacturing process? You think, “Don’t they get all the necessary information from me during their inspections and from my filings?” Well, the answer is yes and no. 

  • FDA’s New Guidance On CMC For Gene Therapy INDs: What You Need To Know
    FDA’s New Guidance On CMC For Gene Therapy INDs: What You Need To Know

    The FDA recently issued for public comment six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy. 

  • How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often
    How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often

    The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. 

  • New Regulations And Safety Complicate Drug Labeling
    New Regulations And Safety Complicate Drug Labeling

    Multinational pharmaceutical companies have for decades manufactured drugs for global distribution. Nevertheless, the task of labeling is becoming increasingly difficult and time-consuming. 

  • How Will The Federal Right To Try Law Impact Drug Development?
    How Will The Federal Right To Try Law Impact Drug Development?

    The passing of the Right to Try Act came after years of debate among politicians, the pharmaceutical industry, and other stakeholders about the potential legal, ethical, regulatory, and business impacts of RTT. That debate is unlikely to end any time soon.

  • How Recent Regulatory & Payer Developments Impact U.S. Biosimilar Access
    How Recent Regulatory & Payer Developments Impact U.S. Biosimilar Access

    In this second installment of a three-part series, industry stakeholders discuss recent developments in the U.S. marketplace from both the regulatory and payer viewpoints, with an emphasis on how these may lead to opportunities for biosimilar manufacturers.

  • Analyzing 2017 FDA Warning Letters Citing Process Validation, Supplier Controls, & OTC Manufacture
    Analyzing 2017 FDA Warning Letters Citing Process Validation, Supplier Controls, & OTC Manufacture

    Shortcomings in data governance/data integrity and are a prominent feature in drug GMP warning letters over the past three years. FDA inspections also focused on contracted services. Additional areas were the subject of FDA investigator attention in CY2017 but may have been overshadowed by these two. This article explores several of those other areas.

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