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

 
  • Regulatory NewsRegulatory News

    UK Details Plans to Tackle Antimicrobial Resistance Over the Next 20 Years

    The UK's Department of Health and Social Care on Thursday released two policy papers detailing the actions the government plans to address antimicrobial resistance (AMR) over the next five years and a global vision for containing AMR by 2040.   Speaking at the World Economic Forum in Davos Switzerland on Thursday, UK Health Secretary Matt Hancock called AMR "as big a danger to humanity as climate change or warfare," and called for an "urgent global response."   Whi...
  • Regulatory NewsRegulatory News

    FDA, EMA and PMDA Plot Harmonized Path for Antibiotics

    Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), met in Tokyo last month to plot out an approach that would allow drugmakers to conduct a single development plan for new antibiotics. The meeting, part of an ongoing effort by the three agencies to spur antibiotic development in light of growing concerns about antimicrobial resistance, was the third between the three ...
  • Regulatory NewsRegulatory News

    FDA, EMA, PMDA Begin Push for New Antibacterials

    The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) met at EMA headquarters in London last week to discuss their role in promoting the development of new antibacterial products. Antimicrobial resistance (AMR) is increasingly being recognized as a global threat to public health, with the World Health Organization (WHO) calling AMR "so serious that it threatens the achievements of modern h...
  • Regulatory NewsRegulatory News

    Woodcock: Antibiotics Pipeline is 'Fragile and Weak'

    At a congressional hearing in Washington, DC on Tuesday, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that current incentives are not enough to overcome the challenges of developing new drugs to fight bacterial infections. Antimicrobial resistance (AMR) is increasingly being recognized as a global threat to public health. In its 2014 Antimicrobial Resistance: Global Report on Surveilla...
  • Regulatory NewsRegulatory News

    Screen-Film Mammography Will Soon be ‘Virtually Obsolete,’ FDA Says

    As quality issues with screen-film mammography continue to crop up, the US Food and Drug Administration (FDA) says facilities are almost done transitioning to full field digital mammography (FFDM) units 15 years after they came into clinical use. Currently, fewer than 400 screen-film units are in use at 5% of the facilities certified under the Mammography Quality Standards Act (MQSA). And although this represents just a sliver of the total mammography units in operation...
  • Regulatory NewsRegulatory News

    FDA Releases 18 Years of Isolate-Level Data for Common Gut Bacteria

    In a move to make its data more transparent and promote scientific research, the US Food and Drug Administration (FDA) is releasing 18 years of data on several bacteria, collected as part of the National Antimicrobial Resistance Monitoring System (NARMS). Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World Health Orga...
  • Regulatory NewsRegulatory News

    World Health Assembly Adopts Action Plan on Antimicrobial Resistance

    In Geneva Monday, members of the World Health Assembly (WHA) endorsed a plan to fight antimicrobial resistance (AMR) on a global scale. Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World Health Organization (WHO) called AMR "so serious that it threatens the achievements of modern medicine." In recent years, health autho...
  • Regulatory NewsRegulatory News

    EU Parliament Calls for Measures to Combat Antimicrobial Resistance

    The European Parliament is calling for new measures to combat antimicrobial resistance (AMR) in Europe, where 25,000 die each year due to drug-resistant infections. Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World Health Organization (WHO) called AMR "so serious that it threatens the achievements of modern medicine." T...
  • Regulatory NewsRegulatory News

    To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information

    A new regulation proposed by the US Food and Drug Administration (FDA) would require manufacturers and sponsors of veterinary antibiotics used in food-producing animals to collect and submit data regarding the use of the drugs in specific animal species. The data is intended to help advance FDA's efforts to promote the "judicious use" of antibiotics as part of a broader initiative to stem the rise of antimicrobial resistance (AMR). Under the 2008 Animal Drug User Fee...
  • Regulatory NewsRegulatory News

    UK Review: New Models Needed to Fight Antimicrobial Resistance

    A review of antimicrobial resistance (AMR), commissioned by the UK and led by internationally renowned economist Jim O'Neill, is calling for billions of dollars in new funding intended to incentivize drug development and head off the threat of drug-resistant disease. Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World He...
  • Regulatory NewsRegulatory News

    Public Health Groups Propose Global Drug Innovation Fund

    Two health advocacy groups, Médecins Sans Frontières (MSF) and the Drugs for Neglected Diseases initiative (DNDi) are urging public health authorities to create a global fund to tackle what they call "deadly gaps in innovation." Citing the rising threat of antimicrobial resistance (AMR), emerging infectious diseases and neglected tropical diseases (NTDs), the two organizations say the pharmaceutical industry is failing to address certain public health challenges. Back...
  • Regulatory NewsRegulatory News

    Global Efforts to Combat Antimicrobial Resistance 'Lacking,' WHO Report Finds

    The World Health Organization (WHO) has completed the first global assessment of national strategies to counter the rise of antimicrobial resistance (AMR). Only a quarter to countries had plans in place to limit the use of antimicrobials, leaving "major gaps" in the struggle against AMR in every region of the world. Background The rise of AMR is tied to the overuse and misuse of antimicrobial medicines such as antibiotics. When microbes targeted by antimicrobial medicin...