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  • Regulatory NewsRegulatory News

    Top CDER officials discuss budget priorities, staffing and COVID

    With negotiations underway for the next iterations of the US Food and Drug Administration’s (FDA) new and generic drug user fee programs, top officials from the Center for Drug Evaluation and Research (CDER) discussed budget and staffing priorities in a call with the Alliance for a Stronger FDA on Friday.   Budget priorities   “We have really made major strides thanks to Congress’ support in the appropriations that we received in 2019, in investing in modernizing t...
  • Regulatory NewsRegulatory News

    EC lays out strategy for effective COVID vaccine rollout

    The European Commission (EC) has set out key steps for effective strategies member states should use to deploy vaccines against COVID-19 when they become available.   In the face of rising numbers of coronavirus cases even in areas of Europe that weathered an earlier surge and had seen numbers subside, the strategies advocated by the EC for member states include first building capacity to deliver vaccines, said EC in a communication to the European Parliament and Cou...
  • ReconRecon

    Recon: Pfizer won’t seek vaccine EUA before election; WHO trial finds remdesivir has little effect on COVID mortality

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer Says It Won’t Seek Vaccine Authorization Before Mid-November ( NYTimes ) ( Reuters ) ( Politico ) Trump’s election-eve drug discounts for seniors get snagged ( AP ) NIH to Study Three Drugs in Treatment of Covid-19 Patients ( WSJ ) ( Reuters ) It took AstraZeneca researchers 1 month to get vaccine trial data to FDA, source tells CNN ( CNN ) US Investig...
  • Feature ArticlesFeature Articles

    EU regulatory tools for RA professionals

    This article provides information on the key sources of information needed for understanding and keeping up-to-date with the European regulation of healthcare products, including medical devices and in vitro medical devices (IVDs), pharmaceuticals/medicinal products, and substances of human origin (blood, tissues, cells, and organs).   Introduction Regulatory professionals who need to understand the European regulation of healthcare products will find that the main s...
  • Regulatory NewsRegulatory News

    FDA officials, experts discuss impact of COVID-19 on cell and gene therapies

    While the US Food and Drug Administration (FDA) is still receiving investigational new drug applications (INDs) for cell and gene therapies, officials are concerned about the impact of the COVID-19 pandemic on clinical trials.   “It’s clear that COVID-19 has adversely affected all aspects of development of cell and gene therapies,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), said at the Alliance for Regenerative Medicine’s M...
  • Regulatory NewsRegulatory News

    FDA releases guidance documents on biocompatibility submissions and nitinol-containing devices

    The US Food and Drug Administration (FDA) has issued two new guidance documents related to premarket submissions on device biocompatibility with intact skin, as well as technical considerations for nitinol-containing devices.   In the draft guidance , issued 15 October, the FDA provided select updates on the type of compatibility information that should be included in premarket submissions for devices made from common polymers and fabrics that come in contact with int...
  • Regulatory NewsRegulatory News

    FDA finalizes biotin interfering testing guidance

    A guidance document from the US Food and Drug Administration (FDA) that addresses biotin interference testing for in vitro diagnostic devices (IVDs) has been finalized. The agency left the 2019 draft guidance largely unchanged, recognizing but declining to address industry concerns seeking a lower biotin cutoff level for interference testing and asking for more explicit information about mitigation measures.   Biotin is used in many IVD scenarios, such as tests for c...
  • ReconRecon

    Recon: FDA approves first Ebola therapy; Advocacy groups push WTO on COVID IP rights

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Chief Defends Vaccine-Trial Halts as Vital to Safety System ( Bloomberg ) Examination shows how widely pharma showers campaign cash at the state level ( STAT ) Vertex, Amgen could be seeking new deals to fuel growth following pipeline stumbles ( STAT ) Vertex shelves experimental rare lung disease drug that once seemed promising ( STAT ) First Ebola thera...
  • RoundupsRoundups

    Euro Roundup: MHRA to join consortium post-Brexit

    The United Kingdom is set to join Australia, Canada, Singapore and Switzerland in a regulatory consortium when it splits from the European Union at the start of next year, enabling companies to access all five markets using a single application.   Since before the 2016 Brexit vote, drug developers have warned that leaving the EU could delay access to new medicine for UK patients. The Medicines and Healthcare products Regulatory Agency (MHRA) has responded to the concer...
  • Regulatory NewsRegulatory News

    During pandemic, FDA permits some respiratory swab, media swaps

    Amid the coronavirus pandemic, the US Food and Drug Administration (FDA) has made new guidance immediately effective that addresses its enforcement policy for modifications to previously cleared molecular tests for other common respiratory pathogens.   During the public health emergency of the COVID-19 pandemic, FDA does not intend to enforce the requirement for obtaining 510(k) clearance for certain modifications of molecular respiratory pathogen tests, including use ...
  • RoundupsRoundups

    FDA Approvals Roundup: New formulation for Ultomiris

    New formulation Ultomiris gets new formulation for blood-related disorders  Alexion’s Ultomiris (ravulizumab-cwvz injection) has been  approved  as a 100 mg/mL formulation for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) and for atypical hemolytic uremic syndrome (aHUS) for adults and children aged one month or older.  The  new  formulation of the complement inhibitor will cut annual infusion time by about 60%, or six hours, compared with the 10 m...
  • Regulatory NewsRegulatory News

    Testing requirements are likely slowing biosimilar entries in the US

    Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation of patent protections to brand-name drug rebates. Now a new analysis, published in the Mayo Clinic Proceedings , suggests that a “high testing bar” for biosimilars to gain regulatory approval is another contributing factor. The analysis found that the median time from the start of a Phase I study to approval by the US Food and Drug Administration (FDA) was more than 5 ye...