REGULATORY ARTICLES

  • EU Drug Safety Through FMD Serialization Readiness
    EU Drug Safety Through FMD Serialization Readiness

    Falsified medicines are a critical challenge to the safety of patients and to the reputation of the pharmaceutical industry. Serialization is a major step toward drug safety across the EU but has brought with it a set of challenges that national authorities and companies are tackling.

  • How FDA, Industry, And Academia Are Guiding AI Development In Biopharma
    How FDA, Industry, And Academia Are Guiding AI Development In Biopharma

    Continuously learning systems (CLS) are artificial intelligence (AI) algorithms that constantly and automatically update themselves as they recognize patterns and behaviors from real-world data — enabling companies to become predictive, rather than reactive, with quality assurance. 

  • EMA’s Revised Format For Risk Management Plans: What You Need To Know
    EMA’s Revised Format For Risk Management Plans: What You Need To Know

    The revised format for the EU Risk Management Plan (RMP) sets a new milestone in a progressive approach to risk management. The new RMP template can be used by RMP experts.

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  • Gene Therapy For Rare Disease — Examining FDA's New Draft Guidance
    Gene Therapy For Rare Disease — Examining FDA's New Draft Guidance

    The FDA recently issued for public comment six draft guidance documents.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. 

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