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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    FDA Offers Draft Guidance on IND Safety Reporting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...
  • 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 and Google Talk 'Adverse Event Trending'

    Last month, representatives from the US Food and Drug Administration (FDA) and search giant Google met to discuss "adverse event trending," Bloomberg reports. Background Currently, FDA keeps track of adverse events submitted through voluntary and mandatory reports to its FDA Adverse Event Reporting System (FAERS). Drugmakers are required to report adverse events to the agency; however, patients and their doctors do so voluntarily, leading to serious underreporting. ...
  • 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

    Plain Language Labeling Regulations to Take Effect in Canada

    Health Canada has released a new guidance document intended to clarify new "plain language" labeling requirements before new regulations take effect on 13 June 2015. Background In 2013, Canada's then-Minister of Health Leona Aglukkaq announced the government was launching a new initiative toimprove drug safety by making product information easier to understand for consumers. Making labels and packaging easier to understand, Aglukkaq said, would "help prevent advers...
  • Regulatory NewsRegulatory News

    Critics Call for Canada to Bolster New Drug Safety Law, Clarify Reporting Requirements

    A critic of Canada's Protecting Canadians from Unsafe Drugs Act —commonly known as Vanessa's Law —argues that without improvements to the country's adverse drug reaction (ADR) reporting systems, the law will fail to meet its goal of improving drug safety. Background Vanessa's Law came into effect on 6 November 2014, after years of campaigning for stricter drug monitoring mechanisms by Conservative Member of Parliament Terence Young. The law was named for Young's d...
  • Regulatory NewsRegulatory News

    WHO Makes Drug Side Effects Easier to Find With New Database

    Last week, the World Health Organization (WHO) boosted its transparency efforts with the launch of a new, open access drug safety database called VigiAccess. Background The practice of postmarket drug monitoring, or pharmacovigilance, is an important part of ensuring patient safety after a product has been approved. During clinical trials, it is not possible to determine every possible side effect or reaction to a drug or vaccine. By monitoring drugs and collecting re...
  • 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

    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

    FDA, CDC Put $18M Behind Adverse Event System for Vaccines

    The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have awarded a new, $18 million contract meant to support its existing Vaccine Adverse Event Reporting System (VAERS) over the next five years. The award will go to Virginia-based SRA International, the company announced in a 17 November 2014 press release . SRA has supported FDA's VAERS program since 1999, it said. VAERS is used by FDA to collect and analyze reports of vacci...
  • Regulatory NewsRegulatory News

    In New Transparency Bid, EMA Expands Drug Adverse Event Reporting Database

    The European Medicines Agency (EMA) is making it easier for patients and industry to keep track of adverse events associated with medicines authorized for use by EMA and other national drug regulatory authorities. Under a massive expansion of EMA's existing ADRreports.EU website, which houses the European database of suspected adverse drug reaction (ADR) reports, consumers can now view suspected ADR reports for drugs regardless of their centrally authorized approval st...