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  • Regulatory NewsRegulatory News

    FDA asks stakeholders to join PDUFA talks by 17 August

    The US Food and Drug Administration (FDA) on Monday called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Prescription Drug User Fee Act program by 17 August 2020.   The monthly periodic consultation meetings take place alongside FDA’s negotiations with regulated industry and are expected to begin the following month.   The call...
  • ReconRecon

    Recon: GSK, Sanofi in talks for £500M UK coronavirus vaccine deal; Regeneron begins Phase 2/3 trial for COVID-19 antibody cocktail

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House teases executive orders on China, immigration and prescription drugs ( Politico ) Regeneron starts COVID-19 antibody cocktail late-stage trials, shares rise ( Reuters ) ( Press ) 2021 Health Plans Granted Leeway To Limit Consumers’ Benefit From Drug Coupons ( KHN ) FDA Commissioner Stephen Hahn won’t confirm Trump’s promises on vaccine timing ( ABC...
  • Regulatory NewsRegulatory News

    Radiologists to FDA: Autonomous AI not ready for prime time

    Artificial intelligence is not ready for autonomy in radiology, according to two radiological professional associations who asked the US Food and Drug Administration (FDA) to wait for more rigorous testing and surveillance of the modality before authorizing its autonomous implementation in medical imaging.   In follow-up to a February 2020 workshop focused on artificial intelligence (AI) in medical imaging, the chairs of the American College of Radiology (ACR) and th...
  • 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...
  • ReconRecon

    Recon: Takeda in for $900M on gene therapy R&D; Vertex gets quick win in England for CF triple therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gottlieb says worst of outbreak will pass by January; Pence sees no need for a mask mandate ( CNBC ) Coronavirus Update: Spooked By America’s COVID-19 Vaccine Skepticism, FDA Promises Not To Lower Standards ( Scrip ) AHA: Hospital losses could top $323B in 2020 ( HealthLeaders ) 2020 Fortune/IBM Watson Health 100 Top Hospitals List ( HITConsultant ) EUSA P...
  • RoundupsRoundups

    FDA Approvals Roundup: Fintepla, Dojolvi, Phesgo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Fintepla gets the go-ahead for Dravet syndrome Zogenix’s Fintepla (fenfluramine) has been approved for the treatment of seizures associated with Dravet syndrome in patients aged 2 years or older. The syndrome is a rare, life-threatening form of epilepsy.   The approval was based on findings from two clinical studies in 202 participants aged ...
  • Regulatory NewsRegulatory News

    FDA: Digital safety data submission to supplant PDFs

    After a successful pilot program, the US Food and Drug Administration (FDA) is fine-tuning a transition to all-digital submission of safety data from clinical trials of investigational drugs.   The goal is to modernize the submission of regulatory data by shifting from use of multiple PDF documents into a digital submission format with structured data elements “that will allow us both to improve the data quality and also allow us to use new analytic tools,” to make oth...
  • ReconRecon

    Recon: Pfizer, BioNTech tout response in early COVID-19 vaccine study; Glenmark charged in price-fixing probe

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US risks 100,000 new Covid-19 cases a day, Fauci warns ( Politico ) Covid-19 vaccine from Pfizer and BioNTech shows positive results ( STAT ) ( WSJ ) Inside Moderna: The Covid Vaccine Front-Runner With No Track Record and an Unsparing CEO ( WSJ ) Trump officials seek to reassure public about safety of a potential coronavirus vaccine ( The Hill ) Ultragenyx wi...
  • Regulatory NewsRegulatory News

    FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold

    In an immediately effective guidance issued Tuesday, the US Food and Drug Administration (FDA) sets its expectations for the development and licensure of vaccines to prevent coronavirus disease (COVID-19), including considerations for manufacturing, nonclinical and clinical studies and post-licensure requirements.   For a vaccine that would be widely deployed against COVID-19, FDA says it expects sponsors to demonstrate that the vaccine is at least 50% effective in a p...
  • Regulatory NewsRegulatory News

    Guidance: FDA holds off on enforcing certain UDI requirements

    The US Food and Drug Administration (FDA) has issued a final guidance for unique device identification compliance dates for Class I and unclassified medical devices. The immediately effective guidance also clarifies agency policy regarding compliance dates for certain devices requiring direct marking.   In the guidance, FDA clarifies that it does not currently intend to enforce standard date formatting, unique device identification (UDI) labeling, or Global Unique Devi...
  • ReconRecon

    Recon: Vertex, NHS reach deal for CF drugs; Canadian court dismisses drugmakers’ challenge to drug price rules

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US After pandemic, US senators want review of drug supply chain ( Reuters ) ( The Hill ) Inovio claims positive results on Covid-19 vaccine but critical data are missing ( STAT ) Companies have raised prices on 245 drugs during pandemic, advocacy group says ( The Hill ) Gilead’s pricing for remdesivir raises questions about the drug’s long-term prospects ( STAT )...
  • Regulatory NewsRegulatory News

    Pediatric anti-infective development addressed by FDA

    The US Food and Drug Administration (FDA) has issued new draft guidance for sponsors who are developing anti-infective drug products for the pediatric population.   The draft guidance notes that pediatric drug development in general comes with some challenges, including the fact that differences not only in body size but also organ maturation and body fluid composition and distribution can affect drug pharmacokinetics and pharmacodynamics in children. Also, some infect...