RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    Hahn: COVID-19 vaccine decision will be "deliberative"

    The commissioner of the US Food and Drug Administration assured physicians and other healthcare providers that vaccine and therapeutics approvals for the COVID-19 pandemic will be “based on good science and sound data.”   “Nothing else will be used to guide our decisions,” said Stephen Hahn, MD, speaking at a virtual meeting held by the Reagan-Udall Foundation on 10 August.   Hahn delivered prepared remarks along with American Medical Association president Patric...
  • Regulatory NewsRegulatory News

    FDA guides drug-drug interaction studies for therapeutic proteins

    A new draft guidance from the US Food and Drug Administration (FDA) gives industry direction in how to assess drug-drug interactions for therapeutic proteins.   The guidance, issued jointly by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) recommends that sponsors use a “systematic, risk-based” approach to determine whether their therapeutic protein candidates for investigational new drug applications (IND...
  • Regulatory NewsRegulatory News

    Pandemic prompts mask, ventilator EUAs from FDA

    This week, the US Food and Drug Administration granted emergency use authorizations (EUAs) to three ventilator-related devices, issued an umbrella EUA for disposable, single-use surgical masks and provided updated information on “in-use time” for certain drugs used to treat patients with COVID-19, the novel coronavirus.   Ventilator-related EUAs The US Food and Drug Administration (FDA) on 4 August issued EUAs for three devices that relate to mechanical ventilation o...
  • Regulatory NewsRegulatory News

    FDA updates bioresearch monitoring e-submission guide

    A technical specifications document regarding bioresearch monitoring technical conformance has been updated by the US Food and Drug Administration.   The guide provides detailed information for electronic submission of clinical trial data (e-CTD) by sponsors in advance of submissions for new drug applications, biologics license applications, and supplemental submissions. The technical specifications document delineates details of the electronic submissions framework la...
  • Regulatory NewsRegulatory News

    EMA addresses risk evaluation, mitigation for nitrosamines

    An updated question-and-answer document from the European Medicines Agency (EMA) provides guidance on handling nitrosamine impurity testing for marketing authorization holders.   Marketing authorization holders (MAHs) are to perform a risk evaluation to ascertain whether chemically synthesized active pharmaceutical ingredients (APIs) are at risk for containing nitrosamines by 31 March 2021. Products containing biological APIs should undergo this first step in risk eval...
  • 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...
  • 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...
  • 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 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...
  • ReconRecon

    Recon: Pfizer-US COVID vax deal details emerge; EC OKs Sanofi's aspart biosimilar

    ​Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  In Focus: US US Price for Pfizer COVID Vaccine Includes Company Distribution Efforts Directed By DOD, CDC ( Pink Sheet ) J&J gets a fresh OK for esketamine, but is it really the game-changer for depression Trump keeps tweeting about? ( Endpoints ) Three More Experimental Therapies Receive Rare Pediatric Disease Designation by FDA ( Global Genes ) Kymera Therapeutics, fresh ...