• Regulatory NewsRegulatory News

    Electronic Informed Consent: Final Q&A Spells Out New Recommendations

    The Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) on Wednesday finalized a question and answer (Q&A) guidance on using electronic systems to obtain informed consent for both HHS-regulated human research and FDA-regulated clinical investigations of medical products. The guidance focuses on procedures to be followed when using electronic informed consent (eIC) to help: Ensure prote...
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    PDUFA VI: Highlights on What to Expect

    The US Food and Drug Administration (FDA) and stakeholders from industry and patient groups on Monday outlined the agreement they forged on the next reauthorization of the Prescription Drug User Fee Act (PDUFA) that begins in 2017, focusing on what’s to come on pre-market reviews, postmarket safety, regulatory decision tools and other ways FDA is preparing for the future of drug development. The meeting follows the July release of the full details of the performance ...
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    FDA Seeks Info on New Tech Helping Conduct Clinical Research

    The US Food and Drug Administration (FDA) on Wednesday announced it's looking for more information on technologies and innovative ways to more efficiently conduct clinical research. The use of smartphones and tablet devices to collect trial participant data seems to be of particular interest to FDA as it's requesting more information on the challenges associated with collecting data on trial participants' own devices, which FDA says may be used to access and respond to ...
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    EMA Announces Sweeping Overhaul of Pediatric Class Waivers

    In a major move, the European Medicines Agency (EMA) announced today it is revoking or revising most product class waivers that allow companies to bypass the requirement to test new drugs in pediatric populations before they can be authorized. Background Companies are often reluctant to conduct clinical studies in children over ethical concerns and fear of adverse events occurring during trials. These reservations have created a gap in the number of products authorized ...
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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 (...
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    FDA Revises Policies on Obtaining Informed Consent in Clinical Trials

    A new draft guidance document issued by the US Food and Drug Administration (FDA) is meant to eventually replace a 16-year-old guide outlining the regulator's views on informed consent. Informed Consent: The Basics As FDA explains in the draft guidance, Informed Consent Information Sheet , when most people think about the process of obtaining consent, they think of it as obtaining written consent from the subject to participate in a medical study. But FDA says this...
  • After Controversy, FDA Finalizes New Policy on Advisory Committee Transparency

    A new guidance document published by the US Food and Drug Administration (FDA) is intended to clarify how financial information about members of its advisory committees should be made available to the public. Background FDA's advisory committees are used regularly to make recommendations regarding regulatory topics, such as the approval of a new drug product or the need for a new regulatory approach. While their recommendations are not binding on the agency, they are ne...
  • India’s CDSCO Issues Guidance on Recording Informed Consent

    India's Central Drugs Standard Control Organization (CDSCO) issued guidance on 9 January 2014 on how to conduct audio-visual recordings of the informed consent process conducted with prospective  clinical trial subjects. The guidance implements an order issued by the CDSCO on 19 November 2013 requiring the audio-visual recording of informed consent for subjects of all domestic and global clinical trials.   The guidance specifies that information about the...
  • India Requires Audio-Visual Record of Clinical Trial Subject Consent

    In compliance with an earlier Supreme Court ruling, India's Office of Drugs Controller issued an Order on 19 November 2013 requiring audio-visual recordings of informed consent by subjects that are to participate in global clinical trials approved between 1 January and 31 August 2013.  The recorded informed consent must be obtained prior to the commencement of the five global trials approved in that time, and the trials my not be undertaken until the necessary ad...
  • After Trio of Disastrous Inspections, Company Enters into Consent Decree with FDA, DOJ

    In February 2013, the US Department of Justice (DOJ) announced it would be making the enforcement of the US Food and Drug Administration's (FDA) current good manufacturing practices (CGMPs) one of its "top areas of focus" for 2013. And while the ultimate effects of that effort have yet to be realized, at least one pharmaceutical manufacturer is now feeling the brunt of DOJ's enforcement activities. Bad Inspections In a 26 August 2013 announcement, DOJ said it has file...
  • Ben Venue, FDA Receive Approval for Consent Decree, Potentially Easing Drug Shortages

    The US Food and Drug Administration (FDA) has received approval from a federal judge for a consent decree of permanent injunction between it and Ben Venue Laboratories, a manufacturing facility long in the crosshairs of the agency's enforcement officials. Background The company, a subsidiary of Boehringer Ingelheim, suspended its manufacturing capabilities in 2011 after receiving a string of warning letters from FDA over the maintenance of its current good manufacturing...
  • Brazil Clarifies Informed Consent Requirements

    Brazil's National Health Surveillance Agency, Anvisa, has released a notice clarifying the rights of individuals who participate as clinical research subjects in the country. The notice specifies that clinical trial subjects must be informed that Brazilian law prohibits compensation for participating in a trial with the exception of being reimbursed for the cost of transportation and meals. The notice also states that a clinical trial subject has the right to lea...