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  • Regulatory NewsRegulatory News

    FDA Explains Why it Waived a Shared REMS for Letairis Generics

    The US Food and Drug Administration (FDA) has released a memorandum explaining why it waived the requirement of a single, shared system (SSS) risk evaluation and mitigation strategy (REMS) for generic versions of Gilead’s Letairis (ambrisentan), which treats pulmonary arterial hypertension. This is just the fourth time in FDA’s history that it has waived an SSS REMS for generic competitors. Because the process of creating an SSS can be time-consuming and complex, such a...
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    Industry Calls for Changes in Two REMS Guidances

    Industry groups representing the pharmaceutical, biotechnology and generic drug industries are calling for changes to two recent US Food and Drug Administration (FDA) draft guidances on risk evaluation and mitigation strategies (REMS).   The draft guidances , released for comment in January, detail a framework for companies to develop an assessment plan for their REMS programs and provide recommendations for surveying patient and health care provider knowledge of REMS...
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    When a REMS is Necessary: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Thursday finalized guidance from 2016 detailing the factors that the agency uses to determine whether a risk evaluation and mitigation strategy (REMS) is necessary for a drug. As defined by the guidance, a REMS is a required risk management plan that can include one or more elements to ensure that the benefits of a drug outweigh its risks. Such elements can include a medication guide, a package insert or a communication plan ...
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    FDA Takes First Steps to Modify TIRF REMS Program

    The Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines is being strengthened by the US Food and Drug Administration (FDA) to better ensure the appropriate patients are receiving these opioids, the agency announced Wednesday. Following an advisory committee meeting on the REMS last August, as well a recently published study in JAMA that found that “thousands of patients receiving TIRFs were opioid-nontolerant...
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    Study Evaluates How an Opioid’s REMS Did Not Work as Intended

    Research published in JAMA on Tuesday details how a US Food and Drug Administration (FDA) class-wide Risk Evaluation and Mitigation Strategy (REMS) did not prevent the inappropriate prescribing of transmucosal immediate-release fentanyls (TIRFs), which were approved solely for breakthrough cancer pain in opioid-tolerant patients. The study, conducted by researchers from the Johns Hopkins Bloomberg School of Public Health and the Center for Science in the Public Intere...
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    FDA Updates List of Brand Name Companies Blocking Generic Applicants

    Back in November 2017, FDA Commissioner Scott Gottlieb called on brand name drug companies to “end the shenanigans” around delaying or restricting generic drug competition. But that call to action has not stopped brand name companies from continuing to pursue at least one gaming tactic, which is refusing to provide samples to competitors looking to bring generic products to market. As part of an effort to deter such a tactic, FDA recently created and updated a list o...
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    Assessing the Effectiveness of REMS: FDA Drafts Two New Guidances

    The US Food and Drug Administration (FDA) on Thursday released two new draft guidance documents aiming to help improve the agency’s ability to ensure that Risk Evaluation and Mitigation Strategies (REMS) put in place for certain drugs and biologics are working properly. The guidances provide industry with a framework to develop a REMS Assessment Plan to better develop a REMS program and improve the quality of the information used to assess the effectiveness of it, and t...
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    FDA Modifies REMS Program for Clozapine

    The US Food and Drug Administration (FDA) announced changes to its risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine, set to take effect on 28 February 2019.   Background   Clozapine, which is marketed as Clozaril, Fazaclo ODT and Versacloz, is an antipsychotic drug first developed in the late 1950s and was first approved by FDA in 1989. Clozapine is indicated for the treatment of schizophrenia in patients whose symptoms are not ad...
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    Gottlieb: 'End the Shenanigans' on Delaying Generic Drug Competition

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday called to "end the shenanigans" that often delay or restrict generic drug competition. The comment followed Gottlieb's discussion of the ways in which brand-name drug companies can use Risk Evaluation and Mitigation Strategies (REMS) or other tactics to prevent generic companies from purchasing drug product to run bioequivalence or bioavailability studies necessary for approval. Federal...
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    REMS Format and Content: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics. The 34-page draft revises 2009 draft guidance for industry known as, "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications." FDA notes at the outs...
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    Gottlieb: Immediate Release Opioids to be Subject to REMS

    FDA Commissioner Scott Gottlieb on Thursday said that immediate-release (IR) opioids will be subject to the same risk evaluation and mitigation strategy (REMS) as extended-release and long-acting (ER/LA) opioids. The agency first required a REMS for ER/LA opioids in 2012. "This week, we issued letters notifying 74 manufacturers of IR opioid analgesics intended for use in the outpatient setting that their drugs will now be subject to a more stringent set of requirements,...
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    Balancing Hatch-Waxman: Stakeholders Weigh in After FDA’s Meeting

    Following a US Food and Drug Administration (FDA) meeting in July on generic drug competition, various stakeholders are offering written comments on reforms FDA and Congress could make to ensure the Hatch-Waxman amendments are not abused. Like others, California Attorney General Xavier Becerra submitted comments calling for pay-for-delay agreement reforms, including legislation to make the deals "presumptively unlawful," reforms to FDA’s citizen petition process a...