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  • Regulatory NewsRegulatory News

    Health Canada Updates Bioavailability Requirements for Highly Variable Drugs

    Health Canada on Monday unveiled new comparative bioavailability requirements for drugs exhibiting large pharmacokinetic within-subject variation in terms of absorption. Although highly variable drugs are generally safe, the Canadian regulator says, the bioequivalence of their formulations is a problem because high variability means that large numbers of subjects are required to give adequate statistical power. In addition, highly variable drugs are poor quality formul...
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    FDA Offers New Bioequivalence Study Guidance for 31 Generic Drug Ingredients

    To help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval, the US Food and Drug Administration (FDA) has published draft product-specific recommendations for 31 different active pharmaceutical ingredients (APIs) and revised recommendations for 11 APIs. The myriad new draft guidance documents focus on what types of bioequivalence (BE) studies may need to be conduct...
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    Researchers Call to Modernize Bioequivalence Standards

    A group of researchers are calling on the US Food and Drug Administration (FDA) to update generic drug regulations, warning that "outdated" bioequivalence standards threaten patient safety. In a paper published in Trends in Pharmacological Sciences last week, the group said that in some cases, switching between branded drugs and their generic counterparts can cause significant issues. This, the authors say, is because the determinations of bioequivalence can result in...
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    Evaluating Next-Generation Sequencing: From Design Concept to Performance Standards

    Discussions are underway on how the US Food and Drug Administration (FDA) plans to develop new ways of regulating next-generation sequencing (NGS) diagnostics. Kicking off a two-day public workshop today, FDA Commissioner nominee Robert Califf said that NGS tests hold great promise for patients, but still present "tremendous uncertainty." The issue, he said, is determining "how accurate [and] how useful can we make the predictions that come from these tests." Califf als...
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    FDA's Final Guidance on Generic Drugmaker Correspondence Addresses Some Industry Concerns

    The US Food and Drug Administration's (FDA) final guidance on controlled correspondence between the agency and the generic drug industry released Monday includes some changes that address industry questions and comments. Background Initially released in August 2014, the draft guidance was the fourth guidance document under the 2012 Generic Drug User Fee Act , and was intended to address formal questions posed to FDA prior to the generic drug review process and to clari...
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    FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi

    A new batch of bioequivalence recommendations issued by the US Food and Drug Administration (FDA) aims to make it easier for generic drug manufacturers to eventually make copies of several popular drugs, including Sovaldi (sofosbuvir), Northera (droxidopa), Xtandi (enzalutamide) and Olysio (simeprevir). Background Bioequivalence recommendations are a critical part of the submission of an Abbreviated New Drug Application (ANDA)—the application generic drug companies subm...
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    FDA Provides Generic Approval Roadmap for 38 Drugs, Including Vertex's Kaldeco

    The US Food and Drug Administration (FDA) has announced the release of new documents meant to make it easier for generic manufacturers to introduce competition to 38 existing drug products, including popular new drugs like Stendra, Belviq, Kalydeco and Brilinta. The documents, known as bioequivalence recommendations, specifically apply to the Abbreviated New Drug Application (ANDA) process—the process by which generic drugs are approved. Generic drugs, unlike new drug...
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    FDA to Study Quality of Long-Acting Generic Drug Products, Including Popular Birth Control Drug

    The US Food and Drug Administration (FDA) is prepared to spend nearly a million dollars over the next two years to study the quality and effectiveness of long-acting generic drug products, including levonorgestrel-based birth control products, the agency announced last week. Overview The announcements, made on the National Institutes of Health's (NIH) website, relate to three separate study proposals focused on long-acting (LA) pharmaceutical products: Title Notice...
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    Small Regulation: FDA Adopts Three Nanotechnology Standards in Last Year

    The US Food and Drug Administration (FDA) has just adopted a new standard on the use of nanotechnology in medical devices—only its third nanotechnology standard yet adopted. Background The new standard, Surface Characterization Of Gold Nanoparticles For Nanomaterial Specific Toxicity Screening: FT-IR Method , was released on 27 January 2015 as part of a major update to FDA's List of Recognized Standards . The standards adopted by FDA are something of a deviation from...
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    India Proposes New Requirements for Bioequivalence Studies

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Central Drugs Standard Control Organization (CDSCO) is soliciting input on a draft guidance that establishes a uniform format for filing requests for the approval of bioequivalence studies that are to be conducted in India on drugs intended for export. The uni...
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    EU Regulators Concerned About Drug Data Fraud by Indian Company

    European regulatory officials have expressed concern that dozens of medicines may have been approved in the EU based on fraudulent data conducted by a contract testing facility in Hyderabad, India. Background In September 2014, French regulator ANSM raised concerns about GVK Biosciences, saying a good clinical practice (GCP) inspection had "raised serious concerns regarding the GCP compliance of the conduct of the clinical part of bioequivalence trials" at the company's...
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    FDA Says it Discovered Problems With Generic Version of ADHD Drug Concerta

    A generic attention deficit hyperactive disorder (ADHD) drug manufactured by Mallinckrodt has been found by the US Food and Drug Administration (FDA) to not be sufficiently equivalent to its reference drug, Concerta. Background Generic drugs are approved through FDA's abbreviated new drug application (ANDA) process. During that process, FDA is primarily concerned with data showing the generic drug is bioequivalent to the reference listed drug (RLD), sometimes referred t...