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

    Updated: FDA delays collection of drug manufacturing volume data

    The US Food and Drug Administration (FDA) on Monday announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical...
  • 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...
  • Feature ArticlesFeature Articles

    Risk management, drug shortages and the EU portal for clinical trials

    Feature articles during May focused on risk management and mitigation in dealing with contractors and vendors and included articles on best practices in good vendor management, use of risk management to support outsourcing activities, testing in-house versus outsourcing, and outsourcing in regulatory operations. Also included were in-depth examinations of challenges and opportunities in “bespoke” therapies, a critical appraisal of drug shortages in Germany and an update on...
  • Feature ArticlesFeature Articles

    Bespoke therapies – opportunities, challenges, and hope

    This article discusses the advent of bespoke therapies, defined as the tailoring of medical treatment to the individual characteristics or symptoms and responses of a patient during all stages of care and as a new frontier beyond personalized medicine. The author covers the revolutionary genetic tools implementing such therapies and the clinical and nonclinical safety perspectives for bespoke therapies. The author concludes that with bespoke therapies we are entering a new...
  • 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...
  • Feature ArticlesFeature Articles

    Drug shortages in Germany ‒ A critical appraisal

    This article discusses drug shortages in Germany, the root causes of production problems with active pharmaceutical ingredients, and drug product manufacturers. The authors offer analysis from the perspective of a medium-sized generic drug manufacturer. They outline a range of reasons for the shortages, all of which point to a “broken marketplace.” The authors conclude with a discussion of mitigation activities and address the current COVID-19 pandemic. They warn that drug...
  • 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...