RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Months into the COVID-19 pandemic, just three therapeutics have been approved to treat COVID-19: dexamethasone in the  United Kingdom  and  Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in  Japan  and Australia.   Convalescent plasma may be used in the US to treat hospitalized patients under an emergency use authorization (EUA) or an investigational new drug application (IND). “Adequate and well-controlled randomized trials remain ne...
  • Regulatory NewsRegulatory News

    Report: FDA REMS program ineffective at curbing opioid misuse

    The US Food and Drug Administration (FDA) has been using the Risk Evaluation and Mitigation Strategies (REMS) program as a way to mitigate adverse events stemming from opioid misuse and abuse, but that program is a poor tool for fighting the opioid epidemic, the Health and Human Services Office of the Inspector General concluded in a new report .   The REMS program is a long-standing drug safety program that has allowed the FDA to require manufacturers to implement ...
  • Regulatory NewsRegulatory News

    FDA gives draft adjuvant trial guidance for RCC, bladder cancer

    Two new draft guidances from the US Food and Drug Administration give investigators a roadmap for clinical trials of adjuvant drug or biologic therapy for two common cancers. The first of the guidances released on 1 October addresses adjuvant treatment for bladder cancer, and the other addresses adjuvant treatment of renal cell carcinoma (RCC).   “Currently, there is significant variability in the design, conduct, and analysis of clinical trials” that examine adjuvant ...
  • Feature ArticlesFeature Articles

    MDR, IVDR, and compliance: A guide for distributors

    Distributors must prepare for new incoming requirements under EU medical device and in vitro diagnostic device regulations. The importance of establishing an effective quality management system, drafting comprehensive contractual agreements and, if required, engaging notified bodies, has created much uncertainty for distributors. To fulfil these new requirements and maintain device supply chains, it is essential for distributors to act early, ensure sufficient in-house com...
  • Regulatory NewsRegulatory News

    Report calls for limits on compounded bioidentical hormone therapy

    Evidence does not support the clinical utility of compounded bioidentical hormone therapies and their use should be limited to patients who cannot use products approved by the US Food and Drug Administration (FDA), according to a consensus study report from the National Academies of Science, Engineering and Medicine (NASEM).   FDA requested the NASEM review due to increasing popularity of compounded bioidentical hormone therapies (cBHT) combined with concerns over he...
  • Regulatory NewsRegulatory News

    Biopharma industry urges MRA to mitigate risk of no-deal Brexit

    The biopharma industry is urging the European Union to separate talks about post-Brexit regulatory cooperation from broader political negotiations. Groups including the European Federation of Pharmaceutical Industries and Associations (EFPIA) made the plea amid fears the collapse of free trade talks will force a hard split between the United Kingdom and EU regulatory regimes.   In a letter to senior EU officials, the six trade groups call for Brexit negotiators to pr...
  • Regulatory NewsRegulatory News

    FDA labeling study helps clear path for OTC naloxone

    Consumers reading a model drug facts label for naloxone could understand labeling sufficiently to use the opioid antagonist safely and effectively without the support of a healthcare provider, according to a label-comprehension study conducted by the US Food and Drug Administration (FDA).   The unusual move by the FDA could help clear a hurdle to approval of over-the-counter injectable and intranasal naloxone; many public health experts concerned about the impact of th...
  • Regulatory NewsRegulatory News

    FDA addresses interstate distribution of compounded drugs in new MOU

    The US Food and Drug Administration (FDA) has developed a standard memorandum of understanding (MOU) with the states that addresses interstate distribution of compounded drugs.   Under the MOU , expected to be signed by 45 states, pharmacy compounders that distribute more than 50% of their compounded drug products interstate will be identified by the states. States will be required to report certain information about these compounders to the FDA.   The 50% thresho...
  • Regulatory NewsRegulatory News

    WHO issues guidance for prequalified products amid COVID-19

    The World Health Organization (WHO) this month issued guidance detailing its expectations and flexibilities during the coronavirus (COVID-19) pandemic for manufacturers, laboratories and contract research organizations taking part in the agency's prequalifications programs. Localized adjustments in processes and procedures may be necessary for manufacturing, clinical trial and testing organizations due to the coronavirus pandemic, but should aim to minimize the risk of ...
  • Feature ArticlesFeature Articles

    Outsourcing in regulatory operations

    This case study explains Project BRIDGE and its vision to centralize process and services, such as dossier planning, compilation and publishing, submission, tracking and archiving to efficiently ensure compliance, increase transparency and maintain or improve quality of submissions to global health authorities. Introduction The author began employment at Boehringer Ingelheim, a large global pharmaceutical company with headquarters in Germany in October 2014. At that ti...
  • Regulatory NewsRegulatory News

    FDA warns against malaria drugs for COVID-19 outside hospital, clinical settings

    The US Food and Drug Administration (FDA) on Friday warned against the use of malaria drugs hydroxychloroquine and chloroquine to treat coronavirus disease (COVID-19) outside hospitals or clinical trials due to serious heart risks.   FDA says it is “aware of reports of serious heart rhythm problems,” including deaths in COVID-19 patients treated with the drugs, either alone or in combination with other QT-prolonging drugs such as azithromycin, and warns that patients w...
  • Regulatory NewsRegulatory News

    Study tracks sharp drop in FDA approvals based on 2 pivotal trials

    The proportion of drugs approved by the US Food and Drug Administration (FDA) on the strength of two or more pivotal trials fell by almost 30 percentage points over the past 20 years, according to an analysis published in JAMA Network Open.   Guidance from the late 1980s, when FDA set down its thinking on the data needed to win approval, indicate that at least two late-phase clinical trials were needed. However, FDA has long deviated from that standard in situations – ...