• Regulatory NewsRegulatory News

    FDA Official Dispels ‘100 Hours’ Myth on Time it Takes to Fill Out Compassionate Use Form

    The simplification of the US Food and Drug Administration’s (FDA) compassionate use process (announced last February and expected to be finalized very soon) may not actually be all that much of a simplification in terms of the amount of time it takes a physician to fill out the form, an FDA official told Focus on Tuesday. Richard Klein, director of the Patient Liaison Program in FDA’s Office of Health and Constituent Affairs, explained to Focus , following Monday’s ...
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    Expedited Compassionate Use for Investigational Drugs Coming Soon, FDA Says

    The fight over patients gaining access to investigational drugs via the compassionate use process is expected to get a lot easier in the near future, just as the US Food and Drug Administration’s (FDA) nonprofit arm, the Reagan-Udall Foundation (RUF), is working to build an online navigator to help patients and physicians understand that process better. Compassionate use, also known as expanded access, is a process by which physicians can request that FDA allow the use o...
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    FDA’s Nonprofit Arm Plots Out New Compassionate Use Navigator

    Patients and physicians desperate for access to a potentially life-saving investigational drug will be able to take some solace in the fact that the US Food and Drug Administration’s (FDA) nonprofit, known as the Reagan-Udall Foundation, is currently working on an online tool to help aid the process of obtaining what are known as "compassionate use" or "expanded access" treatments. The small foundation, which is currently operating with six employees, has drafted a plan ...
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    FDA Sends Three Letters Over Unapproved Zika Diagnostics

    The US Food and Drug Administration (FDA) is taking steps to enforce its oversight of diagnostic tests used to detect the Zika virus, with three new letters to two laboratories and two Texas hospitals for marketing what it says are "high risk" unapproved diagnostics. The letters, sent to MD Biosciences, First Diagnostic Corp. and two Texas hospitals, Texas Children's and Houston Methodist Hospital, call on the recipients to contact the agency within seven days to discuss...
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    Congressional Hearings Focus on Compassionate Use, FDA Issues

    Aside from Thursday’s summit on President Barack Obama’s Precision Medicine Initiative (which can be viewed in its entirety  here ), the Senate and House held two other hearings focused on the inner workings of the US Food and Drug Administration (FDA). At the Senate Homeland Security and Government Affairs Committee hearing, senators discussed FDA’s compassionate use program with the Goldwater Institute’s Dary Olsen, who’s been behind all of the Right-to-Try state legi...
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    European Regulatory Roundup: Brexit Could Lead to New Regulatory Burdens (25 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Industry Leaders Warn Brexit Would Lead to Significant Regulatory Burdens More than 50 leaders of the British biopharmaceutical industry have warned of the regulatory and business upheaval that could result from the United Kingdom leaving the European Union, an event dubbed “Brexit.” In a letter in The Financial Times , the executives argue leaving the EU would result in “s...
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    US, EU & WHO Launch Efforts to Accelerate Zika R&D

    One week after the World Health Organization (WHO) declared a public health emergency in response to Zika-linked clusters of microcephaly, it and authorities in the US and EU are mobilizing to accelerate the development of treatments and diagnostics for the disease. Obama Calls for $1.8 Billion in Funding On Monday, the White House announced it will ask Congress for more than $1.8 billion to establish an emergency fund to combat the Zika virus in the US and abroad. N...
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    FDA and EMA Share Perspectives on Evaluating Ebola Treatments

    Officials from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have shared their perspectives on evaluating treatments for Ebola in two articles appearing in Clinical Trials . The articles discuss some of the challenges the Ebola outbreak presented for studying drugs and vaccines to treat the disease. At the time the outbreak began, no products existed to treat Ebola, and those that were in development had not been tested in humans. Study ...
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    US Preparedness for Public Health Emergencies: Medical Countermeasures and Emergency Use Authorization

    This article discusses how medical products needed during public health emergencies can be made available to the public through the use of FDA's Emergency Use Authorization (EUA). During public health emergencies, the US government must respond quickly. Medical countermeasures (MCMs) are medical products, such as drugs, vaccines and diagnostic tests needed during an emergency. MCMs are developed, manufactured, procured, stockpiled and distributed to protect or treat th...
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    End in Sight for Discussions Over New EU Medical Device Regulations

    New EU regulations for medical devices and in vitro diagnostics (IVDs) could be adopted as early as next year, a European Commission representative told attendees at RAPS' Regulatory Convergence on Tuesday. The legislation would introduce stricter premarket rules for a range of medical devices, increase the powers and responsibilities of notified bodies and require new clinical evidence in some cases. On 5 October 2015, the Ministers of the EU countries agreed on a gene...
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    FDA Releases Draft Guidance on Injectable Drug Dose Labeling

    Citing safety concerns, the US Food and Drug Administration (FDA) is updating its guidance to industry on how to properly label injectable drugs for their appropriate doses. The guidance also updates the agency's definition of single- and multiple-dose containers and retires the term "single-use," in favor of the term "single-patient-use," which the agency says will reduce confusion for some products. Single-Patient-Use The introduction of this new term, "single-patien...
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    How an FDA Proposed Rule for Tobacco Products Could Have a Big Impact on 'Intended Uses' for Devices, Drugs

    Late last month, the US Food and Drug Administration (FDA) unveiled a new proposed rule that many in the pharmaceutical and medical device regulatory communities may have glanced over without a thought because it seemed to pertain only to tobacco products. But on a second look, the rule, if finalized, could have a major impact on the intended use regulations for drugs and devices. For both drugs and devices, an intended use is determined by a manufacturer's expressions, ...