• Regulatory NewsRegulatory News

    What Causes Variations in Review at CDER? It's All About the Designation

    Last year, a study by the Manhattan Institute for Policy Research (MIPR) found variations in review time at the US Food and Drug Administration's (FDA) various drug review divisions were caused by inefficiencies at the agency. Now, FDA representatives are making the case that the variation in review times can be explained by the proportion of applications receiving accelerated review in different therapeutic areas. The MIPR study concluded that the variations in rev...
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    Congress Eyes Wider Use of Third-Party Medical Device Assessments

    A revised version of the 21st Century Cures Act , a bill being considered by the House Energy and Commerce (E&C) Committee, would allow medical device manufacturers to leverage third-party auditors to assess the state of their quality manufacturing systems. The measure, contained within the "Medical Device Regulatory Process Improvements" section of the bill, was first introduced in the original draft of the 21st Century Cures Act , but was removed without expla...
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    FDA Guidance Aimed at Helping to Protect Fish from Certain Drug Products

    A new draft guidance document issued by the US Food and Drug Administration (FDA) calls on sponsors of estrogenic, androgenic or thyroid activity drugs to interact with regulators early on in the review process to help assess the potential impact of their drugs on aquatic wildlife. Background FDA's requirements to conduct environmental testing are the result of the National Environmental Policy Act (NEPA) of 1969. The law required federal agencies to determine t...
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    EU Committee Confirms Increased Risk with Ibuprofen at High Doses

    A European committee has confirmed that high doses of ibuprofen, a popular over-the-counter (OTC) anti-inflammatory drug, can increase a patient's risk for cardiovascular issues. Background Ibuprofen belongs to a class of drugs, called non-steroidal anti-inflammatory drugs (NSAIDs), which includes drugs such as diclofenac, naproxen and aspirin. NSAIDs already have a warning about increased risk of blood clots included in the information distributed with such products ...
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    Leveraging Expedited Programs for Drugs and Biologics for Serious Conditions and Rare Diseases

    In recent years, the US Food and Drug Administration (FDA) has made great advances in the review of new drugs. The US now is reported to lead the world in both timeliness and quantity of noteworthy new drug approvals. 1 This trend is due in part to FDA’s ongoing commitment to improve the drug development process and establish robust, efficient and predictable development programs. As a result, products demonstrating a positive benefit-risk profile and appropriate e...
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    FDA’s Expedited Programs for Serious Conditions: An Overview

    For some serious or life-threatening diseases, few therapeutic options exist. Once a promising therapy is discovered, establishing its clinical benefit and safety profile is necessary but can be time consuming. Standard drug development programs involve formulating and manufacturing the drug product, characterizing the new drug, gathering adequate evidence on its performance, evaluating the safety risks and confirming the effects observed in the early clinical trial...
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    The Key to EU Market Access for Pharmaceutical Companies: Early Engagement

    The path to regulatory approval can be long and arduous. It can also be especially difficult for smaller companies to navigate. But a new report finds that early input from health authorities can help make the process more straightforward. The report is based on information gathered through interviews with small- and medium-sized biotechnology companies, the European Medicines Agency (EMA) and HTA bodies. The report finds early engagement with regulatory authorities an...
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    Study Claims German Dossier Requirements Could Improve Open Access to Trial Data

    A new study conducted by a team of researchers at Germany’s health technology assessment (HTA) body finds that publicly available clinical trial information is “insufficient” compared to full clinical study reports. The researchers, led by Beate Wieseler, head of the department of drug assessment at the Institute for Quality and Efficiency in Health Care (IQWiG), wanted to determine if the reporting requirements for early benefit assessment in Germany yielded more comp...
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    WHO Gives OK to First Rapid-Result Ebola Diagnostic

    The World Health Organization (WHO) has approved the first rapid-result diagnostic test for detecting Ebola. The product, known as ReEBOV Antigen Rapid Test, can help health care workers quickly confirm suspected cases of Ebola. Despite international efforts, Ebola has caused more than 9,400 deaths in West Africa since the outbreak began in March 2014. Rapid Results ReEBOV has a number of advantages over other diagnostics. The product is simple to u...
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    German Price Watchdog Says ‘No’ to 3 Cancer Drugs

    The Institute of Quality and Efficiency in Healthcare (IQWiG) gave negative assessments for three recently approved cancer drugs this month. IQWiG is one of several bodies in Germany charged with conducting health technology assessments (HTAs) for newly approved drugs in Germany. The goal of these assessments is to weigh the benefit of new therapies against the costs to the country’s healthcare system. According to IQWiG’s assessment, the drugs idelalisib , sipuleucel...
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    India’s CDSCO Reduces API Stability Testing Data Requirement

    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) issued a  notice  on 22 October 2014 cutting the long term stability testing data requirement for active pharmaceutical ingredient (API) exports to the EU from 12 months to 6 months based on results from three ba...
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    FDA Finalizes Guidance Aimed at Accelerating Approval for Some Breast Cancer Treatments

    A new final guidance document issued by the US Food and Drug Administration (FDA) outlines the processes by which the regulator will accept surrogate endpoints to support the accelerated approval of treatments intended for high-risk early-stage breast cancer. Background Under normal circumstances, FDA requires "substantial evidence"—generally two Phase III clinical trials—indicating that a product is safe and effective at treating, preventing or curing a given condition...