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  • Regulatory NewsRegulatory News

    Generic Drug Prices ‘Strongly Predictive’ of Shortages, Study Finds

    How a generic drug is priced may be the difference between whether it experiences a shortage or not, a new study published in Value in Health found. The study of commonly used outpatient generic drugs from 2008 to 2014 found that the prevalence of shortages decreased from a peak in 2011-2012 to less than 4% of the overall sample by the end of 2014. Generic drug prices “were strongly predictive of drug shortages,” the researchers found. But competition and market si...
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    FDA Finalizes Testicular Toxicity Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance for drugmakers on identifying and evaluating early signals that could indicate whether a drug might have adverse effects on the testes and when clinical trials are necessary to assess those risks.   Specifically, the 14-page guidance lays out recommendations for identifying nonclinical signals that suggest risk of testicular toxicity; conducting nonclinical assessments to further evaluate the ris...
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    Nearly Half of Recent EU Approvals Based on a Single Pivotal Study

    A recent study found that 45% of marketing authorizations granted in the EU from 2012 to 2016 were based on evidence from a single pivotal trial. The authors of the study, Anne Vinther Morant and Henrik Tang Vestergaard, both employees of Danish drugmaker Lundbeck, say they found the figure to be "surprisingly high," but in line with findings from a recent study of US Food and Drug Administration (FDA) approvals from 2005-2012. Despite the high overall figure, the aut...
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    FDA Disputes Article Highlighting Lackluster Oversight of Postmarketing Studies

    A paper appearing in the New England Journal of Medicine on Thursday argues that the US Food and Drug Administration (FDA) is not doing enough to ensure drugmakers complete postmarketing studies required by the agency at the time their drugs are approved. In 2007, FDA gained the authority to establish postmarketing requirements for new drugs and biologics under the Food and Drug Administration Amendments Act (FDAAA). The act also gave FDA the authority to warn or fin...
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    Early Feasibility Studies for Devices: FDA Highlights Success From Pilot

    In a paper published in the Journal of Vascular and Interventional Radiology last week, two officials from the US Food and Drug Administration (FDA) say that the agency's early feasibility study (EFS) program helped optimize the development of a new type of catheter designed to prevent pulmonary embolisms. The program is part of an effort by FDA to promote more EFSs being done in the US, as device makers often conduct such studies elsewhere before conducting later stud...
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    EMA Seeks Experts on Clinical Data Anonymization

    The European Medicines Agency (EMA) on Wednesday issued a call for experts to join a new technical advisory group for anonymizing clinical data. "Anonymisation of clinical reports poses a major challenge to those directly involved (pharmaceutical industry, clinical research organizations and EMA) and to those accessing the data (patients, healthcare professionals and academia)," EMA says. Specifically, EMA says it plans to form a new committee, referred to as the Techni...
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    FDA Issues Long-Awaited Biosimilar Interchangeability Guidance

    The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability. The guidance, which was initially expected to be published before the end of 2015, recommends that sponsors looking to get a biosimilar approved as interchangeable with its reference product conduct one or more switching studies to show that patients can alternate between...
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    FDA to Further Study Deceptive Drug Advertising

    The US Food and Drug Administration (FDA) says it plans to study how well consumers and healthcare professionals are able to identify deceptive or misleading information in drug advertisements. While FDA says there have been a number of studies in the past looking into the occurrence and influence of deceptive advertising, there hasn't been research into how well consumers and healthcare professionals are able to identify deceptive drug promotion. "The ability to identi...
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    EMA Revises Clinical Data Publication Guidance, Updates on Program

    The European Medicines Agency (EMA) on Friday released a revised version of its guidance on complying with its new policy on the publication of clinical data that went into effect in October . Revised Guidance The revision updates the previous version released in March , which clarified the agency's expectations for the data required to submit for publishing under the agency's clinical trial transparency rules. EMA says it has updated the section on the guidance's sc...
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    FDA Offers Technical Rejection Criteria for Study Data

    For clinical and nonclinical studies starting after 17 December 2016, the US Food and Drug Administration (FDA) is requiring the use of data standards listed in the FDA Data Standards Catalog for all new drug applications (NDAs), biologic license applications (BLAs) and abbreviated new drug applications (ANDAs). Technical rejection criteria is being added to the existing electronic common technical document (eCTD) validation criteria to enforce the deadlines, FDA says. ...
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    FDA: Toxicity Seen in Fatal French Study Does Not Extend to Other FAAH Inhibitors

    The U.S. Food and Drug Administration (FDA) on Friday said that after reviewing the safety information of a first-in-human clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January, the agency found that the toxicity exhibited in the trial does not extend to other drugs in the class, known as fatty acid amide hydrolase (FAAH) inhibitors. Working alongside the European Medicines Agency (EMA) and ...
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    Generic Topical Patches: FDA Offers Draft Guidance on Adhesion Studies

    Generic drugmakers submitting clinical studies on the adhesive performance of a transdermal delivery system (TDS) or topical patch will want to take note of new draft guidance released Tuesday from the US Food and Drug Administration (FDA). This guidance describes the recommended approach to an adhesion clinical study design used to support an abbreviated new drug application (ANDA) and, once finalized, the guidance will supersede FDA’s prior recommendations related to a...