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  • Regulatory NewsRegulatory News

    Oncology research mid-pandemic: Challenges may bring durable innovation

    Though clinical research in general has been challenged during the COVID-19 pandemic, oncology trials “have several unique considerations due to disease severity, regimen complexity, and acute care requirements” that have caused even greater challenges, US Food and Drug Administration (FDA) officials wrote in a new viewpoint published in JAMA Oncology .   Data integrity issues and “pandemic-induced protocol deviations” are a concern for sponsors and FDA alike, and the...
  • Regulatory NewsRegulatory News

    CDRH FY 2021 guidance slate includes post-EUA transition plan

    Surgical staplers and laparoscopic power morcellators are among devices that made the grade for the US Food and Drug Administration’s (FDA’s) slate of final guidance topics for fiscal year 2021. The agency also plans to draft a transition plan for devices that have received emergency use authorizations (EUAs) during the pandemic.   The Center for Devices and Radiological Health (CDRH) at FDA released the list of draft and final guidance documents it plans to issue in f...
  • ReconRecon

    Recon: New healthcare investing record; Sanofi slim-down, sell-off?

    Recon:   Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cuomo: Public should be 'very skeptical' about COVID-19 vaccine ( The Hill ) Dr. Scott Gottlieb: U.S. in 7th inning of the pandemic but the ‘hardest part’ is likely ahead ( CNBC ) For Trump, Covid-19 therapeutics are the new vaccines ( STAT ) Whatever happened to Deborah Birx? ( The Hill ) What about the German negotiation model? Biden steers ...
  • Regulatory NewsRegulatory News

    CDER launches quality management maturity pilots for APIs and finished dosage forms

    Two new pilot programs related to manufacturing quality management have been launched by the US Food and Drug Administration (FDA).   The agency’s Center for Drug Evaluation and Research (CDER) is hoping to “gain insight from third-party assessments of a manufacturer’s quality management system to inform future development of an FDA rating system,” according to CDER’s announcement to industry of the new pilot programs.   One pilot program will characterize quality ...
  • Regulatory NewsRegulatory News

    FDA reissues Chinese respirator EUA, but freezes new additions

    The emergency use authorization (EUA) for certain types of filtering face-piece respirators has been reissued by the US Food and Drug Administration (FDA) as the public health emergency of the COVID-19 pandemic continues. However, only respirators already authorized under the document's earlier version will be covered under the reissued umbrella EUA.   The umbrella EUA was extended for certain filtering face-piece respirators made in China and not approved by the Natio...
  • 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

    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...
  • 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...