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  • Regulatory NewsRegulatory News

    FDA Casts Doubts on 3D-Printed PPE, Clarifies Digital Health Policies for COVID-19

    The US Food and Drug Administration has cautioned health care professionals that 3D-printed personal protective equipment (PPE) may not provide the same level of protection as conventional products.   “3D-printed PPE may provide a physical barrier, but 3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators,” according to a new FAQ from the agency.   The explainer comes after comp...
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    Notifying FDA of Drug Shortages During the Pandemic: FDA Offers Guidance

    With an eye on drug supply disruptions, the US Food and Drug Administration (FDA) on Friday published new guidance on how manufacturers should notify FDA of permanent halts or interruptions to manufacturing certain products that are likely to lead to a meaningful disruption in supply. An FDA spokesman told Focus that so far, only one firm is reporting a shortage of one human drug. FDA previously declined to name the firm or the drug, citing confidential commercial i...
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    EMA Signs Off on Conditional Authorization for Novartis Gene Therapy

    The European Medicines Agency’s Committee for Advanced Therapies on Friday announced that it has recommended a conditional authorization for Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec) as a treatment for babies and young children with spinal muscular atrophy (SMA), a rare and often fatal genetic disease. EMA’s recommendation is based on the preliminary results of one completed clinical trial and three supporting studies in patients with SMA with differ...
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    FDA Warns Irish Company for Marketing Unapproved COVID-19 Treatments

    As there are still no approved treatments for COVID-19, the US Food and Drug Administration (FDA) this week warned Ireland-based Carahealth for offering unapproved herbal products and other products referred to as “Immune Tonic” on its website to mitigate, prevent, treat, diagnose or cure COVID-19. The warning letter, released publicly on Friday, follows the distribution of warning letters to seven companies for making fraudulent and unsupported claims about products,...
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    FDA Lifts Requirements for Masks, Respirators, Looks to Reprocessing to Ease Shortages

    As the supply of critical personal protective equipment (PPE) dwindles amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) is lifting requirements for certain masks and respirators to increase their availability.   In a 10-page guidance explaining its enforcement policy for masks and respirators used during the COVID-19 public health emergency, FDA explains what regulatory requirements it is lifting for different types of masks a...
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    FDA Ends CSR Pilot, Plots New Approach for Disclosing Study Reports

    The US Food and Drug Administration (FDA) on Thursday officially ended a fledgling pilot program that was part of an effort to provide more transparency on the drug approval process. The agency said it’s working on a new approach to disclosing study reports. Last June, the agency was already pushing away from the clinical study report (CSR) pilot because of lackluster participation (FDA noted that  Janssen was the only sponsor  that agreed to participate) and said it wo...
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    ICH Cancels Vancouver Meeting, Opens Consultation on Residual Solvents Guideline

    The International Council for Harmonisation (ICH) has joined a growing list of organizations and agencies around the world to cancel meetings and workshops as a result of the coronavirus disease (COVID-19) pandemic.   On Wednesday, ICH cancelled its upcoming meeting in Vancouver, Canada originally slated for May. “ICH has considered this very exceptional measure to be necessary in view of the evolving COVID-19 situation worldwide and global travel restrictions in place...
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    European Commission Adopts Revised Standards to Speed Devices to Market

    As part of work to facilitate a faster and less expensive conformity assessment procedure for those marketing certain medical devices, the European Commission earlier this week adopted revised harmonized standards. The commission's implementing decisions relate to the medical devices, in vitro diagnostics and active implantable medical devices directives. The revised standards are meant to speed the production of medical face masks, gloves, containers for intravenous in...
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    Coronavirus Relief Bill Includes OTC Drug User Fee Program

    A wide-ranging $2 trillion coronavirus emergency relief bill is expected to become law tomorrow and included in it are provisions not only related to drug and medical device shortages and COVID-19 testing, but also a new user fee system for over-the-counter (OTC) drugs. Overall, the bill is meant to provide relief to the struggling economy and to help government agencies and health facilities as more than 70,000 in the US now have COVID-19 and as the rate of new infecti...
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    EMA Offers Methodological Considerations for Trials During COVID-19 Pandemic

    The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline on points that clinical trial sponsors should consider on the implications of  the coronavirus disease (COVID-19) on methodological aspects of ongoing trials. While noting that “it is not possible to give general applicable advice on how the different aspects related to the pandemic should be handled, as implications on clinical trials are expected to be manifold,” the EMA’s...
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    FDA Eases Import Requirements for Devices and PPE to Fight Coronavirus

    To increase the availability of personal protective equipment (PPE) and other medical devices amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Tuesday eased import requirements for certain products.   Typically, companies importing FDA-regulated products are required to submit entry information to the agency for the products.   However, to ease burdens on importers and speed up the entry process for PPE and certain devi...
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    Gilead Asks FDA to Rescind Orphan Designation for COVID-19 Antiviral

    In a reversal, Gilead said Wednesday that it submitted a request to the US Food and Drug Administration (FDA) to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19. Earlier in March, Gilead was granted the designation because the potential antiviral would help to treat COVID-19, which currently affects fewer than 200,000 patients in the US. If the company had kept the designation and remdesivir w...