• Feature ArticlesFeature Articles

    Expanded Access Programs: Making Compassion Work

    • 20 April 2018

    This article discusses issues and efforts related to expanded access programs aimed at providing patients with quicker access to new and experimental drugs, many of which are potentially lifesaving. The perspectives of health authorities, industry and patients are explored as well as the historical legal and ethical issues involved in ensuring expanded access drugs are safe and efficacious.

  • Feature ArticlesFeature Articles

    Orphan Drug Development Progress

    • 20 April 2018

    This article discusses how orphan drug development has benefitted from a decade of collaboration between FDA and EMA and how other stakeholders have continued to help accelerate the progress after FDA and EMA joined forces to establish an "orphan cluster group" aimed at stimulating the development of orphan drugs. The author reviews how the orphan drug designation has expanded since 2008 and how the number of new drugs available to patients with rare diseases has increased. The article concludes with recommended future steps to continue the progress in developing and bringing orphan drugs to patients suffering from rare diseases.

  • Regulatory NewsRegulatory News

    Opioid Epidemic: FDA Drafts Guidance on Developing Depot Buprenorphine Products

    • 20 April 2018
    The US Food and Drug Administration (FDA) on Friday released the first of two draft guidance documents explaining the agency’s current thinking on drug development and clinical trial design issues relevant to the study of sustained-release “depot” buprenorphine products (i.e., modified-release products for injection or implantation) to help those with opioid use disorder.

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