• Regulatory NewsRegulatory News

    FDA issues guidance on resuming or initiating BE studies amid pandemic

    New guidance from the US Food and Drug Administration (FDA) issued on Friday provides recommendations for resuming or initiating bioequivalence (BE) studies for generic drugs during the COVID-19 pandemic.   The guidance, aimed at ensuring participant and study staff safety, calls on generic drug developers to carefully consider protocols for resuming or initiating BE studies and to take steps to ensure the scientific validity of data generated from studies impacted by ...
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    Australia Looks to Improve Generic Drug Authorization Process

    Australia’s Therapeutic Goods Administration (TGA) announced Thursday that it’s considering a range of options to improve the generic medicine registration process. Chief among those options is TGA’s consideration to allow the use of overseas reference product in bioequivalence studies, as currently the reference product used in such studies must be an existing medicine approved in Australia. “Our requirements are largely consistent with comparable overseas regulator...
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    FDA Consults on ICH Biopharmaceutics Classification System-Based Biowaivers Guideline

    The US Food and Drug Administration (FDA) on Thursday released its version of the International Council for Harmonisation (ICH) biopharmaceutics classification system (BCS) -based biowaivers guideline for consultation.   The draft guideline, which reached Step 2b of the ICH process in June, is currently under consultation by the group’s regulatory members and is expected to be adopted in May 2019. FDA is asking interested parties to submit their comments on the guideli...
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    FDA Finalizes Guidance on Waivers for Bioavailability and Bioequivalence Studies

    The US Food and Drug Administration (FDA) on Friday finalized guidance for sponsors who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study requirements for immediate release (IR) solid oral dosage forms based on an approach termed the Biopharmaceutics Classification System (BCS). The guidance, finalized from a 2015 draft, explains what is necessary for sponsors of investigational new drugs (INDs) and applicants of new drug ...
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    Tracking Post-Approval Study Completion: Majority On-Schedule but Not Submitted

    The US Food and Drug Administration (FDA) on Thursday released its most recent report tracking the progress that new drug and biologic applicants are making on post-approval studies. The report found that the majority of post-marketing requirements (PMRs) and post-marketing commitments (PMCs) are progressing on schedule, though of those studies that are open (734 NDAs and 156 BLAs are open as of 30 September 2016) and on-schedule, few PMRs for new drug applications ...
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    Drugged Driving: FDA Finalizes Study Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on how drugmakers should study the effects of their drugs on driving ability. The guidance is largely in line with the draft version issued in 2015, and continues to recommend that drugmakers follow the "tiered assessment" approach detailed in a 2011 report from the National Highway Traffic Safety Administration's Office of Behavioral Safety Research. FDA first introduced the draft guidance after ...
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    Rare Diseases: FDA Awards Grants for 21 Clinical, Natural History Studies

    The US Food and Drug Administration (FDA) on Friday awarded $32 million in research grants to fund 15 clinical studies and six natural history studies for rare diseases. The grants are being funded through FDA's orphan products grants program , with $22 million going to the clinical studies and $9.8 million in combined funding from FDA and the National Center for Advancing Translational Sciences' (NCATS) Therapeutics for Rare and Neglected Diseases program going to fund...
  • Feature ArticlesFeature Articles

    Bioequivalence Studies of Solid Oral Dosage Forms Overview

    The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US. Introduction 'Generic' drugs offer a significant cost saving and are ...
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    FDA Finalizes 46 Bioequivalence Guidances

    In its continued push to support the development of generic drugs, the US Food and Drug Administration (FDA) on Friday finalized 46 product-specific bioequivalence guidances. The guidances, which lay out FDA's expectations for the studies that should be done to demonstrate that a generic drug is bioequivalent to its reference product, give specific recommendations for what analytes to measure, what dissolution test methods and sampling times Some of the guidances also s...
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    Former CDC Director: Medicine Should Look Beyond Randomized Controlled Trials

    In an article in the New England Journal of Medicine on Thursday, former director of the US Centers for Disease Control and Prevention Thomas Frieden calls for greater use of alternative data sources, other than randomized controlled trials (RCTs), for health care decision making. "For much, and perhaps most, of modern medical practice, RCT-based data are lacking and no RCT is being planned or is likely to be completed to provide evidence for action. This 'dark matter'...
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    EMA Updates Guidance on Three Post-Authorisation Activities

    The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations. "The main aim is to improve the quality of post-authorisation applications by better assisting applicants in complying with the legal and regulatory requirements and avoiding frequent mistakes," EMA writes. Specifically, the updates include a new pre-submission c...
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    FDA Publishes 21 New, 13 Revised Draft Generic Drug Guidances

    • 13 July 2017
    The US Food and Drug Administration (FDA) on Thursday published the 21 new and 13 revised draft guidance documents to help generic drugmakers conduct bioequivalence studies. FDA is announcing the availability of a new draft product-specific guidance for industry for drug products containing the following active ingredients: FDA is seeking feedback on the drafts before it begins work on the final versions of product-specific guidance. FDA  last issued  a batch of s...