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    FDA Looks to Strengthen Expanded Access Program

    The US Food and Drug Administration (FDA) on Thursday unveiled plans to further strengthen its expanded access program, as the controversial Right to Try legislation has yet to help any patients.   The expanded access program allows patients with serious or immediately life-threatening diseases who are unable to participate in clinical trials to gain access to promising investigational treatments.    Over the last five years, FDA has authorized more than 9,000 appl...
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    Boehringer Cites ‘Massive’ Number of Patents in Humira Biosimilar Suit

    As six companies have now settled with AbbVie over when they can launch their Humira (adalimumab) biosimilars in 2023, Germany-headquartered Boehringer Ingelheim continues to wrangle in court with the Chicago-based AbbVie.   According to documents released Wednesday from the suit between Boehringer and AbbVie, Boehringer said AbbVie’s generalizations “are unproductive and inaccurate.” The comments from both sides offer a window into a dispute that’s continued now for m...
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    Drugmakers Seek Clarity on Guidance on Use of Placebo and Blinding in Oncology Trials

    A half-dozen biopharma companies are seeking further clarity from the US Food and Drug Administration (FDA) regarding draft guidance from August on using a placebo in certain oncology trials. The draft features FDA’s thoughts on the ethical challenges of using a placebo in randomized controlled clinical trials for therapies to treat hematologic malignancy and oncologic disease. The draft also discusses blinding and unblinding, patient reported outcomes (PROs) and prac...
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    Democrats, Republicans Prep to Take Up Drug Prices Together

    Following the House’s transition Tuesday to a Democratic majority, Senate Majority Leader Mitch McConnell (R-KY) said Wednesday that he will work with House Democrats on crafting a plan to tackle high prescription drug prices.   “I can’t imagine that won’t be on the agenda,” McConnell said regarding prescription drug prices. Potential House speaker Nancy Pelosi (D-CA) also further indicated that representatives and senators on both sides of the aisle will look to find ...
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    Meta-Analyses of Randomized Trials: FDA Offers Draft Guidance

    The conducting of meta-analyses to evaluate safety questions presents a unique opportunity to detect and quantify the risk of a safety event and may help provide a more precise estimate of the risk of uncommon serious adverse events by combining information from multiple trials, the US Food and Drug Administration (FDA) said Tuesday as it released new draft guidance. The 26-page draft defines meta-analysis as the “combining of evidence from relevant studies using approp...
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    Real World Data App: FDA Releases Open Source Code

    The US Food and Drug Administration (FDA) on Tuesday released computer code and a technical roadmap to allow researchers and app developers to use the agency’s newly created app that helps link real world data with electronic health data supporting clinical trials or registries. FDA said the app and patient data storage system can be reconfigured by organizations conducting clinical research and can be rebranded by researchers and developers who would like to customize ...
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    FDA's CDER Warns California Company for Inaccurate Listing

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released a warning letter sent to Cerritos, CA-based United Exchange Corp. for including inaccurate information in a listing of an unidentified product. The listing deficiency, first detailed by FDA to the company in a 5 February letter, was still uncorrected even after FDA sent a data removal notification to the company on 22 March. “Section 510(j) of the Federal Fo...
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    FDA Fires Back Over Teva Suit on Restasis 180 Days of Exclusivity

    Teva has “earned nothing, let alone entitlement to 180-day exclusivity,” the US Food and Drug Administration (FDA) said in a court filing this week after Teva filed suit last month over its first filer status regarding generic versions of Restasis (cyclosporine). Calling Teva’s demands “baseless and premature,” the agency noted that although Teva submitted its abbreviated new drug application (ANDA) for a cyclosporine generic in January 2012, Teva has yet to win FDA app...
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    Health Groups Say New NAFTA Will Slow Biosimilar, Generic Competition

    The Association for Accessible Medicines (AAM), AARP, Kaiser Permanente and more than a dozen other groups are raising concerns with the recently renegotiated version of the North American Free Trade Agreement (NAFTA), now known as the U.S.-Mexico-Canada Free Trade Agreement (USMCA). The groups say the USMCA leans too heavily in favor of the biopharma industries and will “exacerbate the problem of high prescription drug prices” in the US. More specifically, the group...
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    FDA Begins Preparations for New NDC Coding System

    With the US Food and Drug Administration (FDA) running out of National Drug Code (NDC) numbers in the next decade or so, a public meeting on Monday discussed multiple options for how to amend a code that affects just about every part of the US health care system. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, kicked off the meeting noting how ubiquitously NDCs are used – from e-prescribing to adverse event reporting to track and trace to reim...
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    Class I and Unclassified Device UDIs: FDA Pushes Back Enforcement Dates by 2 Years

    The US Food and Drug Administration (FDA) released new guidance Friday that effectively pushes back by two years the date by which FDA will enforce certain unique device identifier (UDI) requirements for class I and unclassified devices. The new dates by which FDA said it will enforce for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices are: 24 September 2020, for the following requirements: Standard date fo...
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    FDA Approves New Opioid Opposed by Markey and Others

    The US Food and Drug Administration (FDA) on Friday approved a new opioid, AcelRx Pharmaceuticals’ Dsuvia (sufentanil sublingual tablet), despite objections from Sen. Ed Markey (D-MA), Public Citizen and the chair of the advisory committee that reviewed the medicine. The agency also sent a complete response letter for Trevena’s New Drug Application (NDA) for the pain medicine oliceridine.   In explaining the approval FDA Commissioner Scott Gottlieb said that Dsuvia, ...