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  • Regulatory NewsRegulatory News

    FDA Offers Draft Guidance on IND Safety Reporting

    For investigational new drug application (IND) sponsors running clinical trials and debating when a serious adverse event can be linked to an investigational drug and is serious enough to unblind data, FDA offered new draft recommendations on Wednesday. The new guidance on IND safety reporting follows previous guidance on Safety Reporting Requirements for INDs and BA/BE Studies from 2012 and contains specific details on: The composition and role of a safety assessment ...
  • Regulatory NewsRegulatory News

    Tufts CSDD Raises Questions over Adverse Event Reporting in US

    Inconsistencies in the way adverse event reports are filled out and sent to the US Food and Drug Administration (FDA) could mislead drug safety professionals and cause the wrong conclusions to be drawn, in addition to myriad other issues, according to a report from the Tufts Center for the Study of Drug Development released Wednesday. Background FDA has three adverse event reporting forms it uses to collect data on drugs (prescription and non-prescription), biologics, m...
  • Regulatory NewsRegulatory News

    FDA to Explore Criteria for Quarterly Medical Device Malfunction Reporting

    The US Food and Drug Administration (FDA) has announced it will pilot a new initiative to explore criteria for allowing medical device manufacturers to report malfunctions of certain low- and medium-risk devices on a quarterly basis. Medical Device Malfunction Reporting In 2007, the Food and Drug Administration Amendments Act (FDAAA) made changes to the Food, Drug, and Cosmetic Act (FD&C) , requiring makers of certain class I and class II devices to report malfuncti...
  • Feature ArticlesFeature Articles

    Managing Pharmacovigilance in Digital Health Initiatives

    • 14 August 2015
    This article analyzes adverse event reporting obligations and identifies ways to reduce regulatory risk and cost associated with digital health initiatives. The pharmaceutical industry, most would agree, has been slow to embrace the use of digital technologies, such as the cloud and mobile devices, in delivering healthcare. As with social media, pharmaceutical company involvement in digital health presents many difficult questions, making executives uneasy. Among...
  • Regulatory NewsRegulatory News

    FDA to Soon Require Medical Device Companies to Submit Adverse Event Data Electronically

    The US Food and Drug Administration (FDA) is reminding manufacturers and importers of medical devices about an upcoming requirement to submit all adverse event reports electronically. Background The shift was made final in February 2014 under a final rule, Medical Device Reporting: Electronic Submission Requirements . While medical device manufacturers have long been required under 21 CFR 803 to report known or suspected adverse events to FDA, the regulator has tra...
  • 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

    EU Committee Takes on Adverse Event Reporting for Veterinary Drugs

    Regulators at the European Medicines Agency (EMA) are concerned that adverse events may be underreported for veterinary drugs. In an effort to address the issue, the agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has published a reflection paper intended to boost adverse event reporting. Background EMA, along with national regulators, is tasked with monitoring and collecting post-market surveillance data on veterinary medicines. This is done prima...
  • Regulatory NewsRegulatory News

    US FDA Amends eMDR Rules to align with Unique Device Identification Program

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. US medical device regulators at the Food and Drug Administration (FDA) have issued correcting amendments  to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system. All changes will affect federal regulation 21 CFR Part...
  • Regulatory NewsRegulatory News

    FDA, CDC Preparing Updated Form to Record Vaccination Problems

    The US Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) are calling for comments on a new adverse event reporting form for vaccines meant to replace the current paper-based reporting form. Background In a notice published in the Federal Register on 24 November 2014, CDC said it's accepting public input on its proposed Vaccine Adverse Event Reporting System (VAERS) 2.0 form. VAERS is used by FDA and CDC, which co-administer th...
  • Regulatory NewsRegulatory News

    Proposed Rule Calls for Clinical Trial Results to be Reported, Even When Product Isn't Approved

    The US Department of Health and Human Services (DHHS) today unveiled new proposed requirements for its online clinical trials register, ClinicalTrials.gov, that will require pharmaceutical and medical device companies to submit more information regarding patient enrollment, the progress of trials and the results of those trials--even when a product is never approved in the US. Background Under section 801 of the Public Health Service Act (PHSA) , as amended by the Foo...
  • Regulatory NewsRegulatory News

    Is Google a Key Part of the Future of Drug Safety? FDA Researchers Say 'Yes'

    Could the US Food and Drug Administration (FDA) soon use Google to track drug-related adverse events? In a new research letter published this week in Clinical Pharmacology & Therapeutics, two FDA researchers argue that "Internet search logs" could be substantially useful to the agency's drug regulatory staff in determining which drugs might have unforeseen adverse events. Background At present, FDA tracks those adverse events through a hybrid voluntary/mandatory rep...
  • Regulatory NewsRegulatory News

    EMA Prepares to Free up Clinical Trials Results Starting Next Month

    In less than a month, pharmaceutical companies operating in the EU will need to begin posting clinical trial results in the European Clinical Trials Database (EudraCT) under a new plan meant to expand the amount of information available to consumers. Background The plan was first announced by the European Medicines Agency (EMA) in October 2013, when it said that an update to EudraCT, dubbed EudraCT V9, would enable pharmaceutical companies to post new types of...