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  • Regulatory NewsRegulatory News

    Wide swath of online opioid sellers warned by FDA

    Seventeen website operators recently received warning letters from the US Food and Drug Administration (FDA) for selling unapproved and misbranded opioids. The letters were issued on 31 August 2020 to operators of websites based in China, Iceland, India, New Zealand, Pakistan and the United States.   Operators of the websites, which carry names such as “www.buydrugsmedsonline.com” and “www.beststeroidstore.net,” were warned for offering opioids such as oxycodone and tr...
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    FDA seeks input on genotyping for pediatric codeine use

    The US Food and Drug Administration (FDA) is seeking public consultation on whether children under the age of 12 years should be permitted to receive analgesics containing codeine, if they have been cleared from having a genetic tendency to metabolize the drug at potentially toxic levels.   Currently, the use of products containing codeine is contraindicated in children under the age of 12. Codeine, an opioid indicated for relief of mild to moderate pain under some cir...
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    FDA takes aim at online opioid sellers with new pilot

    The National Telecommunications and Information Administration (NTIA) will partner with the US Food and Drug Administration (FDA) in a pilot aimed at reducing the online sale of illicit opioids.   During the 120-day pilot, FDA will notify participating internet registries when a website operator does not respond adequately, or within the required time frame, to a warning letter. An agency of the US Department of Commerce in the Executive Branch, NTIA oversees telecom...
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    Interview: FDA’s Cohen on OTC naloxone labeling study

    An over-the-counter formulation (OTC) of naloxone could expand the availability of a life-saving tool in addressing the opioid crisis, since the medication can rapidly and safely reverse opioid overdose. The US Food and Drug Administration (FDA) has developed a model consumer label for OTC naloxone and conducted a consumer behavior study; these results were published this week in the New England Journal of Medicine .   RELATED: FDA labeling study helps clear path...
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    FDA labeling study helps clear path for OTC naloxone

    Consumers reading a model drug facts label for naloxone could understand labeling sufficiently to use the opioid antagonist safely and effectively without the support of a healthcare provider, according to a label-comprehension study conducted by the US Food and Drug Administration (FDA).   The unusual move by the FDA could help clear a hurdle to approval of over-the-counter injectable and intranasal naloxone; many public health experts concerned about the impact of th...
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    FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones

    The US Food and Drug Administration (FDA) on Thursday released new draft guidance on its benefit-risk assessment framework for opioids, outlining how the agency plans to compare the effectiveness and safety of new opioids with already approved opioids. The idea for a comparative approval standard, discussed by former FDA Commissioner Scott Gottlieb in March before a Senate committee, hinges on the fact that “FDA believes that there should be a premarket demonstration ...
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    CDER Develops New Method to Evaluate an Opioid’s Safety Risk

    As fentanyl analogs present a major risk to public health, and as these analogs can evade prosecution, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has developed a new computational approach to understand these often-unidentified chemicals better and to assist with drug scheduling. The new approach, called Public Health Assessment via Structural Evaluation (PHASE), can evaluate the similarity of a newly identified drug of ab...
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    Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals

    Nonprofit advocacy group Public Citizen on Thursday filed a citizen petition calling for the US Food and Drug Administration (FDA) to impose a moratorium on approving new or reformulated opioids until the agency implements recommendations from a 2017 report by the National Academies of Science, Engineering and Medicine.   The petition is undersigned by Raeford Brown, the chair of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee who has spoken out again...
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    FDA Plots New Ways to Address Opioid Epidemic in 2019

    While acknowledging “past mistakes” related to the opioid epidemic, the US Food and Drug Administration (FDA) on Tuesday drew up new actions it will take to stem the crisis in 2019. The comments and commitments from FDA follow a report from "60 Minutes"  last Sunday questioning if FDA enabled an expansion of the opioid epidemic. But moving forward, FDA says it has new tools to help combat the crisis. For instance, passage of the Support Act last October has provided...
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    Woodcock Lays Out Top CDER Priorities for 2019

    While noting that the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has reached some important milestones in 2018, CDER Director Janet Woodcock also unveiled the center’s priorities for 2019 at the CMS/FDA Summit in Washington, D.C. on Tuesday. “We’ve generally accomplished what we set out to do” in 2018, she said, noting that in the generic drug space, “we’ve reached a steady state,” while in the new molecular entity (NME) space...
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    Opioids Compromise: What’s in it for FDA

    The US House and Senate late Tuesday reached a consensus on a conglomeration of opioids legislation that will have far-reaching effects for the US Food and Drug Administration (FDA). Among the provisions that will affect FDA include allowing the agency to require prescription opioids to be packaged in a three- or seven-day blister packs, further collaboration with the Customs and Border Protection (CBP) to stop illegal opioids at the border, new public meetings and guid...
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    FDA Plots Policy Priorities for 2018

    The US Food and Drug Administration (FDA) on Thursday announced its priorities for policy activity in 2018, which will include reducing the misuse and abuse of opioids, promoting generic drug and biosimilar competition, creating a total product lifecycle office for medical devices, advancing digital health technologies and strengthening the agency’s workforce. “Our work is taking place during an inflection point in both science and policy,” FDA Commissioner Scott Go...