• RF Quarterly

    RF Quarterly, September 2022: Regulatory strategy

    Welcome to the September issue of RF Quarterly in which global regulatory experts write about the key elements of regulatory strategy throughout the product lifecycle, CMS regulatory strategy, the application of project management strategies to postapproval CMC submissions, and medical writing strategies for aligning regulatory documents with strategic goals.   We thank the authors for their generosity in sharing their knowledge and expertise with the RAPS regulatory c...
  • Feature ArticlesFeature Articles

    June’s Regulatory Focus: Nutrition in health and disease management

    Feature articles in June examined food safety in China, US Food and Drug Administration (FDA) guidance on supply chain disruptions, possible updates to the US Dietary Supplement Health and Education Act (DSHEA), and FDA and Federal Trade Commission (FTC) regulation of dietary supplements intended for treating or preventing certain mental health disorders.   Safety, disruptions, and responsive policy  China has improved its overall food safety situation significant...