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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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    Key Concepts to Enhance Regulatory Communication and Ethics in the Current Environment

    This article discusses the current regulatory environment and presents several ideas for enhancing communication among regulatory and cross-functional teams. The author presents three key concepts for achieving this, including the flow of knowledge and information, senior regulatory presence with minimal hierarchy and applying appropriate regulatory strategies for achieving timely approvals and cites RAPS core values for maintaining regulatory ethics.   Introduction ...
  • ReconRecon

    Recon: House Passes $2T Stimulus, Heads to Trump for Signature; Vertex Joins List of Drugmakers Halting New Studies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US House passes historic $2 trillion stimulus despite objections from GOP lawmaker ( CNN ) ( WSJ ) Irate House lawmakers scramble back to DC amid fears of coronavirus vote delay ( Politico ) ( Reuters ) The US Now Leads the World in Confirmed Coronavirus Cases ( NYTimes ) After Considering $1 Billion Price Tag for Ventilators, White House Has Second Thoughts ( NY...
  • Regulatory NewsRegulatory News

    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,...
  • TrackersTrackers

    COVID-19 Vaccine Tracker

    Welcome to the Regulatory Focus COVID-19 Tracker , your go-to resource for information on COVID-19 vaccine development.   On 11 March, the World Health Organization classified the COVID-19 outbreak as a pandemic. The disease has reached nearly every country, infecting hundreds of thousands of people and killing thousands.   Currently, there are no FDA-approved therapies or vaccines for SARS-CoV-2, the virus that causes COVID-19. The National Institute of Allergy...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • RoundupsRoundups

    EU Regulatory Roundup: MHRA Offers Advice on Managing Clinical Trials During COVID-19 Outbreak

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Offers Advice on Managing Clinical Trials During COVID-19 Outbreak   The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has provided guidance on how to manage clinical trials during the COVID-19 outbreak. With the pandemic and government responses to it disrupting studies, the MHRA guidance offers sponsors advice on how to deal with...