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  • Feature ArticlesFeature Articles

    Marketing Exclusivity for Over-the-Counter Switched Products

    This article discusses the regulatory process for changing a drug's status from "prescription only" to Over-the-Counter (OTC) and discusses issues related to gaining exclusivity for OTC switched products under FDA regulations and guidance and Congressional legislation. Introduction Prior to the enactment in 1951 of the Durham-Humphrey Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) , a pharmaceutical manufacturer could decide whether to market a product...
  • Feature ArticlesFeature Articles

    Overview of the US Rx-to-OTC Switch Process

    This article provides an overview of the US prescription (Rx) to Over-the-Counter (OTC) switch process, including full switch and partial switch, speaks to the importance of self-care for consumers, and discusses potential areas of opportunity for sponsors and/or industry. Introduction Nonprescription products empower consumers to make informed decisions in selecting appropriate Over-the-Counter (OTC) product(s) for their condition. By increasing the number of produ...
  • Feature ArticlesFeature Articles

    The Challenges and Strategies for Today's Rx-to-OTC Switch Programs

    This article presents the background, approaches and regulatory considerations for prescription to Over-the-Counter (Rx-to-OTC) switch programs. The US Food and Drug Administration (FDA) has conservative expectations for the studies supporting a switch in terms of methodologies and sample sizes. Because of this, other countries will sometimes give consideration of consumer studies conducted in foreign countries on a case-by-case basis, in place of studies conducted in th...
  • Regulatory NewsRegulatory News

    FDA Finalizes HIV Drug Development Guidance

    The US Food and Drug Administration (FDA) has added more detailed definitions for treatment-naïve and treatment-experienced HIV patients and provides recommendations for designing switch trials, according to guidance finalized Monday. The agency hopes the guidance will "promote and facilitate more drug development in the heavily treatment-experienced population," an FDA spokesman told Focus , by introducing a trial design using "an endpoint of virologic efficacy within ...
  • Regulatory NewsRegulatory News

    Ireland Considers Switching 12 Medicines to OTC Status

    Ireland's Health Products Regulatory Authority (HPRA) has published a list of twelve active ingredients (or combinations of ingredients) that are currently classified as prescription-only medicines (POM) which it believes could safely be made available to consumers over-the-counter (OTC). There are currently 34 drugs approved in Ireland that contain one of the ingredients included on the list, including medicines for the treatment of migraine, acid reflux, hay fever, ...
  • Full Information From FDA OTC Switch Meeting Released

    The complete information from the 23 March over-the-counter switch meeting between the US Food and Drug Administration (FDA) and industry and public stakeholders has been made public. FDA is currently considering whether to create regulations that would make it easier for consumers to buy medications that are currently prescription-only. The so-called "over-the-counter (OTC) switch" would make some popular medications available OTC if they can be used safely with minimal...
  • FDA Looking to New Paradigms for Getting Drugs to Patients More Quickly

    The US Food and Drug Administration (FDA) is evaluating whether to upend several approval pathways, including the current over-the-counter (OTC) pathway with one that emphasizes more OTC medicines available to patients with chronic conditions, reports Bloomberg . FDA Commissioner Margaret Hamburg and Center for Drug Evaluation and Research Director Janet Woodcock said that FDA is looking to hold a public hearing in March to discuss the possibility of accelerating how ...