• Regulatory NewsRegulatory News

    EHR Data in Clinical Trials: New FDA Draft Guidance

    The US Food and Drug Administration (FDA) on Monday released draft guidance to assist clinical trial sponsors, investigators, contract research organizations (CROs), institutional review boards (IRBs) and other using electronic health record (EHR) data in FDA-regulated clinical investigations. The 12-page guidance is meant to facilitate the use of EHR data in clinical trials and “promote the interoperability of EHRs and electronic systems supporting such trials.” Prepa...
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    CBER Unveils New Electronic Reporting System for Vaccine Adverse Events

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday announced the availability of an electronic submission system for companies to submit adverse events linked to vaccines. The launch of the system, which is part of the Vaccine Adverse Event Reporting System (VAERS) run jointly by FDA and the Centers for Disease Control and Prevention, follows guidance released in August 2015 that offers recommendations on the ele...
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    Health Canada Finalizes IVD Labeling Guidance After 18 Years

    The Canadian regulatory agency Health Canada on Friday finalized its guidance for labeling in vitro diagnostic (IVD) devices nearly 18 years after releasing the draft version in 1998. The final guidance includes new considerations for electronic labeling, IVDs with small containers, blood glucose monitors and information on complying with Canada's Official Languages Act , which requires product labels to be written in both French and English. Additionally, the guidance...
  • Feature ArticlesFeature Articles

    Race to Comply with FDA ESG Guidelines

    For life sciences companies, paper-based commercial material submissions do not cut it anymore, not only when it comes to automating processes for improved efficiency, but also in the face of rapidly approaching new regulatory guidelines on electronic submissions from FDA. This article discusses the urgency as well as the findings of a 2015 global commercial content management study. Each year, life sciences companies send more than 80,000 promotional material submissi...
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    Sentinel, iPod-Based Devices can Match Patients to EHRs in Public Health Emergencies

    A recent study funded by the US Food and Drug Administration (FDA) found that an iPod Touch-based platform and FDA's Sentinel system could be used to accurately track the safety of drugs and vaccines dispensed during public health emergencies. The platform, called the handheld automated notification for drugs and immunizations (HANDI), uses an application running on an iPod touch, fitted with a card reader and barcode scanner, to record patients' information from a drive...
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    Streamlining the Regulatory Review Process in Pharma: The Upcoming Transition to Electronic Common Technical Documents

    • 13 January 2016
    [Editor's note: RAPS will be hosting an eCTD workshop 13-14 April. More details here .] Regulatory Focus Interviews Steve LoCastro and Sharen Johnson, West Pharmaceutical Services For pharmaceutical companies, filing Common Technical Documents (CTDs) is a critical aspect to the regulatory approval process. Historically, this process has been paper-centric until recently. This exclusive interview features a recent collaborative effort between West Pharmaceutical Ser...
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    FDA, Industry See Progress in MDUFA IV Negotiations

    At the second meeting focused on the fourth iteration of the Medical Device User Fee Agreements (MDUFA) for 2017, both the US Food and Drug Administration (FDA) and industry reiterated agreement that the program overall has improved and is heading in a positive direction. The negotiations center on the use of a system whereby medical device companies pay fees to FDA to register their establishments and list their devices with the agency. The fees help FDA increase the ef...
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    Electronic Application Forms Mandatory for EU Centralized Procedure

    Beginning today, the European Medicines Agency (EMA) will require companies to use new electronic application forms (eAF) for all medicines applying to the centralized procedure. Background In March 2012, EMA piloted the use of electronic application forms as part of its efforts to modernize the marketing authorization process. Since then, EMA has allowed companies to submit their initial marketing authorization applications in either electronic or paper format. Then i...
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    EMA Holds Final Round of Testing Before New Electronic Forms are Required

    The European Medicines Agency (EMA) is conducting user-acceptance testing of new electronic application forms (eAF) in preparation for the transition to electronic-only applications on 1 July 2015. Background In February, EMA announced it would require all new human and veterinary medicines using the centralized procedure, including variations and renewals, to use eAFs as opposed to paper applications. EMA began using electronic application forms for marketing au...
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    FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years

    Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week. Background FDA has received electronic submissions from drug companies since at least 2003, when it adopted the International Conference on Harmonisation's (ICH) electronic common technical document (eCTD). The submission standard is used by many of the world's top regulatory bodies, incl...
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    FDA's Electronic Drug Labeling Proposal Comes Under Fire

    The US Food and Drug Administration (FDA) is coming under fire from patient safety groups and US legislators who say the agency's attempt to require certain drug labeling information to be distributed electronically instead of on paper "package inserts" could put patients at risk. Background In December 2014, FDA released a long-anticipated proposed regulation, Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Prod...
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    FDA Says it's OK With Modernizing the Clinical Trial Informed Consent Process

    New guidance issued by the US Food and Drug Administration (FDA) could make it easier for companies to conduct clinical trials by explaining how federal regulators will permit companies to use electronic media like interactive websites to help facilitate the informed consent process. Background In the US, clinical trials are regulated by FDA and the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under Chapter 21, Section 50.25 of the Code of Federal Regulations (...