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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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    GAO Raises Questions on FDA’s Orphan Drug Designation Process

    The Government Accountability Office (GAO) announced Friday that it has found that the US Food and Drug Administration (FDA) does not always ensure that all information is consistently recorded and evaluated when making orphan drug designation determinations. The missing of these critical steps by the agency in some cases means that FDA reviewers do not fully understand the context of a drug’s intended use for the rare disease, GAO said. “The Commissioner of FDA shou...
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    CDRH’s Case for Quality Pilot Gains Momentum

    The pilot program led by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) aimed at manufacturing and product quality has gained momentum this year, with dozens of waived post-approval and risk-based inspections among participating firms.   The pilot program is collectively run by CDRH and the FDA-funded public-private partnership Medical Device Innovation Consortium (MDIC) and the CMMI Institute under CDRH’s 2014 Case for Qua...
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    FDA Spotlights Recent Spike in Drug Shortages

    The US Food and Drug Administration (FDA) is not just seeing an increase in drug shortages but also a spike in the intensity and duration of shortages, according to agency presentations at an FDA/Duke Margolis Center for Health Policy event on Tuesday. Matthew Rosenberg, an economics staffer at FDA, looked at drug shortages in terms of occurrence, duration, intensity and public health impact. Combining data from FDA archives and IQVIA national sales database, Rosenbe...
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    FDA Works to Reduce Dog Testing in Drug Development

    US Food and Drug Administration (FDA) researchers are working to develop a new informatics model to reduce the reliance on dogs to conduct studies in animal drug development.   The agency’s new study, which was proposed on Friday, is intended to aid animal drug developers in conducting certain research without the need for product testing on dogs.   Animal drug developers would be able to use the new model as a mechanism for comparing blood levels of certain oral...
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    FDA Hands Akorn 483 Over GMP Issues at New Jersey Site

    In an inspection report released Friday, the US Food and Drug Administration (FDA) details 11 observations from an inspection of Akorn’s Somerset, New Jersey facility in July and August of this year.   This is the second Form 483 Akorn has received in 2018. In May the company was handed a Form 483 listing a total of 13 observations from an inspection of the company’s Decatur, IL facility, the third inspection report issued for that facility in three years.   Form ...
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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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    Mylan Pharmaceuticals Pledges to Resolve FDA Citations Over Quality Control Failures

    Following the 13 nonconformities that were revealed during a US Food and Drug Administration (FDA) inspection of a Mylan Pharmaceuticals manufacturing site, Focus obtained a copy of the company’s response to the agency via a Freedom of Information Act (FOIA) request. The response to the 31-page Form 483, which was issued after the FDA visit to the plant in Morgantown, WV earlier this year, outlines a total of 77 commitments to address the inspectional observations....
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    CDRH Looks to Expand Case for Quality Program

    With plans to establish a full program next year, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) recently met its goal to complete at least 30 appraisals under the voluntary case for quality (CfQ) pilot program by year’s end. CDRH had already completed a total of 35 appraisals across 18 device companies, as of earlier this month, in collaboration with the Medical Device Innovation Consortium (MDIC) and the CMMI Institut...
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    Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance

    The US Food and Drug Administration (FDA) on Thursday released its priorities for addressing compounded drugs in 2018 after years of developing policies to improve its oversight. Background In recent years, FDA has worked to update its policies on compounded drugs in response to a 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least 60 deaths and new requirements brought on by the Drug Quality and Security Act (DQSA) of 201...
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    FDA Looks Ahead and Back on Orally Inhaled and Nasal Generic Drugs

    The US Food and Drug Administration (FDA) has come a long way when it comes to locally acting orally inhaled and nasal drug products (OINDPs) and in the next five years of generic drug user fees, the agency is looking at further progress on some unique challenges, according to a regulatory science report on OINDPs. Background FDA’s Office of Generic Drugs (OGD) explained how the performance of OINDPs has been notoriously difficult to characterize because of a lac...
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    FDA Details New Manufacturing Quality Pilot Program

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last month released details on its upcoming voluntary medical device manufacturing and product quality pilot program as part of its Case for Quality (CfQ) initiative. "CDRH envisions a future state where the medical device ecosystem is inherently focused on device features and manufacturing practices that have the greatest impact on product quality and patient safety," FDA write...