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  • Regulatory NewsRegulatory News

    FDA provides guidance on preparation and submission of pediatric study plans

    In a final guidance document, the US Food and Drug Administration provides sponsors with a detailed framework for how to prepare and submit pediatric study plans. The final guidance supplants a draft guidance published in 2016.   The new pediatric study plan guidance follows on from regulations and laws promulgated in the late 1990s and early 2000s that addressed the dearth of pediatric data in drug development. These rules aimed to increase pediatric studies for exclu...
  • RoundupsRoundups

    FDA Approvals Roundup: Monjuvi, Spravato, Epidiolex

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Monjuvi okayed as novel therapy for diffuse large B-cell lymphoma MorphoSys’ Monjuvi (tafasitamab-cxix IV infusion) has been approved for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).   The novel CD19-directed cytolytic antibody is indicated in combination with lenalidomide for patients with DLBCL, i...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS unveils new Member Knowledge Center

    Following shortly after the launch of its new Member Dashboard , RAPS has unveiled a completely revamped and improved online Member Knowledge Center . RAPS members can now log in via RAPS’ website and use the center to find, view and access exclusive member content, including courses, videos, on-demand webcasts, publications, books, reference documents and other regulatory educational materials. More than 1,000 member benefit resources are available via the center. Th...
  • ReconRecon

    Recon: US strikes $1B deal for J&J COVID-19 vaccine; Prosecutors seek up to $18B from Purdue

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to pay $1 billion for 100 million doses of Johnson & Johnson's COVID-19 vaccine candidate ( Reuters ) ( FT ) US government begins two trials testing Eli Lilly’s coronavirus antibody drug ( CNBC ) Justice Department Seeks as Much as $18.1 Billion From Purdue Pharma ( WSJ ) ( Reuters ) Novavax’s Covid-19 vaccine shows promising immune response, early data sho...
  • Regulatory NewsRegulatory News

    EC floats cross-sector health innovation partnership

    In a draft document issued 29 July, the European Commission (EC) unveiled its plan for integration of health technology capabilities across the European Union (EU). The plan was lauded by five pharmaceutical and medical technology associations who signed on to a joint statement welcoming the proposal.   Dubbed the Partnership for Health Innovation, the initiative aims to facilitate translational work by creating an EU-wide “health research and innovation ecosystem,” to...
  • Feature ArticlesFeature Articles

    The Canadian application process and alternate pathway for COVID-19‒related clinical trials

    This article offers an overview of the clinical trial application process and guidance on the regulatory obligations pursuant to Part C, Division 5, of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” in Canada. The authors focus on clinical trial applications only for biologics (schedule D) and pharmaceuticals (schedule F). They provide information on a range clinical trial submission requirements and communication with Health Canada’s re...
  • ReconRecon

    Recon: Abbvie cans pacts with Voyager; Bayer sees compounded troubles with COVID-19

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Generic drug approvals still winning the pandemic at US FDA ( Pink Sheet ) BARDA Begins Stockpiling APIs For Critical Drugs ( Pink Sheet ) Report: GoodRx files for IPO ( MedCity News ) CymaBay Reports Positive Results for Seladelpar in Patients with Primary Biliary Cholangitis ( Global Genes ) BARDA drafts Fujifilm Diosynth into its vaccine production effort, of...
  • Regulatory NewsRegulatory News

    FDA touts advanced manufacturing to address COVID shortfalls

    Advanced manufacturing techniques can be employed to help address some of the manufacturing and supply chain problems the US has seen during the COVID-19 pandemic, Stephan Hahn, Food and Drug Administration (FDA) commissioner, and Anand Shah, FDA deputy commissioner for medical and scientific affairs, wrote in a blog post on the FDA website. “The potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, whic...
  • RoundupsRoundups

    Asia-Pacific Regulatory Roundup: India permits export of some PPE, diagnostic kits

    India’s Directorate General of Foreign Trade (DGFT) has relaxed restrictions on the export of personal protective equipment (PPE) and diagnostic kits imposed in response to the coronavirus outbreak and will authorize successful applicants to ship set amounts of the products to other countries.   As the COVID-19 pandemic spread around the world, DGFT stopped Indian manufacturers from exporting PPE and other needed products. DGFT has begun trying to partly lift the restr...
  • Regulatory NewsRegulatory News

    FDA Purple Book Database now includes all CBER-, CDER-licensed biological products

    The US Food and Drug Administration (FDA), in updating the Purple Book, its database of FDA-licensed biologic products, will also include exclusivity information for biological products as well as a glossary. Biosimilar and interchangeable biological products are included in the searchable online database.   The current list of products maintained by the Center for Biologics Evaluation and Research (CBER) will not be further updated by FDA.   The agency explained t...
  • Regulatory NewsRegulatory News

    MedWatch to Manufacturers program retired in favor of FAERS dashboard

    The US Food and Drug Administration (FDA) is retiring its MedWatch to Manufacturers program, saying the FDA Adverse Event Reporting System (FAERS) public dashboard has largely supplanted the functions served by the MedWatch (MMP) program.   Since 2017, said the agency, the FAERS dashboard has given sponsors the ability to search for voluntary adverse events reports and download the reports directly. “The dashboard allows applicants to obtain the information on voluntar...
  • Regulatory NewsRegulatory News

    FDA authorizes first two semi-quantitative COVID-19 serology tests

    The US Food and Drug Administration has authorized the first two serology tests that report semi-quantitative data about past infection with SARS-CoV-2, the virus that causes COVID-19 infection.   “Being able to measure a patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection may be useful as we continue to learn more about the virus and what the existence of antibodies may mean,” said Tim Stenzel, MD, PhD, director of the Office of In Vi...