• Regulatory NewsRegulatory News

    FDA’s Office of New Drugs Director to Retire

    After nearly 25 years of service at the US Food and Drug Administration (FDA), John Jenkins , M.D., Director of the Office of New Drugs (OND), will retire from the federal government on 6 January 2017. For the past 15 years, Jenkins has led OND in its difficult tasks of setting US standards for new drugs’ safety and efficacy, overseeing the clinical testing of investigational drugs and reviewing marketing applications under Prescription Drug User Fee Act (PDUFA) time...
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    GAO Report Highlights Ongoing Challenges in Oversight of Drug Compounders

    A new report by the Government Accountability Office (GAO) finds that while the US Food and Drug Administration (FDA) has taken steps to improve its oversight of drug compounders, challenges at both the state- and FDA-level remain. Background Unlike traditional drugmakers, drug compounders are exempt from certain requirements of the Federal Food, Drug and Cosmetic (FD&C) Act . These exemptions allow compounders operating under section 503A of the act to produce drugs w...
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    Brexit Rejig: UK Taps Three Leaders to Helm Office for Life Sciences

    The UK’s Office for Life Sciences, which will continue to be a joint unit across the Department of Health (DH) and the newly formed Department for Business, Energy, and Industrial Strategy (BEIS), on Thursday selected three new ministers to lead. In the DH, two ministers will be jointly responsible for life sciences, including: Lord Prior of Brampton, Parliamentary Under Secretary of State for Health and former adviser to the health authority of Abu Dhabi, who will lea...
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    FDA Unveils IRB Draft Guidance on Written Procedures

    The US Food and Drug Administration (FDA) and the Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) have released new draft guidance on the written procedures institutional review boards (IRBs) are expected to maintain and follow. IRBs are used to approve and oversee human research in order to ensure that participants are adequately protected. Under federal regulations, IRBs are required to maintain and follow written procedures...
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    FDA Kicks Pharma, Device Rule Finalizations Down the Road, Past Obama’s Presidency

    The US federal government is notoriously slow at promulgating new rules and bringing them into enforcement. But the US Food and Drug Administration (FDA) is taking that slowness to a whole new level for a host of potentially controversial final and proposed rules, some of which have lingered for decades. On Friday, the US Department of Health and Human Services (HHS), which FDA operates under, released its semiannual inventory of rulemaking actions under developm...
  • Feature ArticlesFeature Articles

    FDA's New Office of Pharmaceutical Quality

    The Center for Drug Evaluation and Research Office of Pharmaceutical Quality (OPQ) was launched in 2015. This article examines FDA's reasons for implementing a major change to oversight of manufacturing quality and the implications for consumers, sponsors and regulatory professionals. The Future of Quality FDA has been and continues to be committed to assuring quality (i.e., safety and efficacy) medicines are available to the American public. FDA implemented quality o...
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    Senators Urge Obama to Take Action on Drug Prices

    Policy solutions to bring down the rising tide of prescription drug prices should be included in next year’s budget, eight senators said in a letter sent to President Barack Obama on Tuesday. Examples of ways Obama could help to lower drug costs include requiring drugmakers to provide rebates on prescriptions for Medicare Part D low-income subsidy enrollees “in the same way that it does already for Medicaid recipients,” the senators said, noting that about $120 billion c...
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    FDA Promotional Enforcement Actions Hit Record Low in 2015

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a record-low nine letters to companies for advertising and promotion violations. While OPDP has seen a general downward trend in issuing action letters in recent years, 2015 marks the first time the office has issued fewer than 10 letters in a single year. In 2014, OPDP issued 11 letters, though it would later go on to retract one letter to Pacira Pharmaceuticals and li...
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    FDA to its Scientists: Feel Free to Engage on Social Media

    The US Food and Drug Administration (FDA) is now encouraging its employees to use social media in a personal capacity, particularly for sharing information that may benefit public health, as long as employees make clear that their opinions aren’t the views of the agency. The new policy, released last week, clarifies that employees do not need to obtain permission or approval from FDA supervisors or agency management to use social media in a personal capacity, although “e...
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    Walking the Digital Tight-Rope

    On behalf of the Regulatory Focus Board of Editors, we would like to introduce you to a collection of articles on the regulatory oversight of advertising, labeling and social media. Most likely, you are currently reading this on your iPad, smart phone or computer screen as are the majority of people seeking information in this digital-age. To align with current user-practices, Regulatory Focus magazine moved to a completely digital format in 2012. Along the same vein,...
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    NICE to Work Earlier With Industry to Speed NHS Adoption of New Drugs, Devices

    The UK's National Institute for Health and Care Excellence (NICE) on Tuesday officially launched its Office for Market Access (OMA) to collaborate more closely with industry to accelerate the adoption of new drugs, devices and diagnostics by the National Health Service (NHS). Specifically, OMA will give commercial stakeholders access to a dedicated team at NICE that they can approach for inquiries relating to health technology evaluation, as NICE is responsible for...
  • Feature ArticlesFeature Articles

    Correlation Between OPDP Untitled or Warning Letters and OIG Settlements or Corporate Integrity Agreements with Sponsors

    This article discusses the existence of a correlation between OPDP enforcement letters and OIG settlements or corporate integrity agreements with pharmaceutical companies. Pharmaceutical companies promote their prescription drug products for a number of reasons, including to increase consumer awareness and the number of physicians prescribing the drugs and ultimately, to drive sales. Since these prescription products may carry serious risks, their promotion is r...