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    Researchers: Patient Reported Outcomes for Heart Failure Fail to Meet FDA Criteria

    A team of researchers say that no currently available patient-reported outcomes for heart failure meet the US Food and Drug Administration's (FDA) criteria for supporting product approval. In a recently published review in the Journal of the American College of Cardiologists , the researchers checked the patient-reported outcomes against nine criteria adapted from the 14 listed in FDA's 2009 guidance, Patient-Reported Outcome Measures: Use in Medical Product Developme...
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    Biosimilar User Fees: FDA and Industry Reach Agreement

    The US Food and Drug Administration (FDA) and representatives of the biotechnology industry have reached an agreement on the second iteration of the Biosimilar User Fee Act (BsUFA II) following 14 meetings from March through May. Specifically, the two sides have settled on the draft commitment letter that represents the agreements made over the course of the negotiations, which initially began in December 2015. Similar to FDA's other user fee programs, BsUFA is a ...
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    EMA and FDA Begin Collaborations on Patient Engagement

    The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Wednesday began exchanging more information on the best practices of involving patients in the development, evaluation and post-authorization tracking of medicines. The EMA/FDA teleconference, also known by EMA as a "cluster," on patient engagement seeks to increase the exchange of information on engaging with and involving patients and their organizations within the regulators’ wor...
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    Senators, Experts Weigh Bipartisan Bill to Stop REMS Abuses

    The Senate Judiciary Committee on Tuesday held a meeting with a panel of experts to discuss a recently introduced bill that seeks to stop branded drug companies from misusing Risk Evaluation and Mitigation Strategies (REMS) to withhold access to drug samples for bioequivalence testing necessary for bringing generic drugs to market. Background The bill, known as the CREATES Act and introduced last week , focuses on two tactics often employed by the branded drugmakers to...
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    New Senate Bill Aims to Close Regulatory Loopholes Blocking Generic Drug Competition

    Members of the Senate Judiciary Committee introduced bipartisan legislation on Tuesday that seeks to stop anticompetitive practices brand name drug companies often use to thwart or delay the entry of less-expensive generic versions of their products. Backed by 19 physician, pharmacist, hospital and consumer groups, including the Generic Pharmaceutical Association (GPhA), Public Citizen and the largest US pharmacy benefit manager, Express Scripts, the bill, known as the ...
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    Woodcock: Antibiotics Pipeline is 'Fragile and Weak'

    At a congressional hearing in Washington, DC on Tuesday, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that current incentives are not enough to overcome the challenges of developing new drugs to fight bacterial infections. Antimicrobial resistance (AMR) is increasingly being recognized as a global threat to public health. In its 2014 Antimicrobial Resistance: Global Report on Surveilla...
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    FDA Outlines Medical Device Real-World Evidence User Fee Proposal

    Negotiations over the fourth iteration of the Medical Device User Fee Act (MDUFA) continued late last month and into May, with the US Food and Drug Administration (FDA) outlining plans for a new user fee proposal linked to real-world evidence (RWE). The RWE proposal is part of FDA’s counter proposal for the reauthorization of MDUFA, which was presented to industry on 4 March, and would cost $329 million above the cost of MDUFA III. In a meeting on 25 April (the meeting ...
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    New Bill Would Speed FDA Review of OTC Contraceptives

    Editor's note: This article has been updated to clarify that the Oregon bill allows pharmacists to prescribe certain contraceptive drugs to patients. A new House bill, sponsored by Rep. Mia Love (R-UT), would speed the review of contraceptive drugs by the US Food and Drug Administration (FDA), and includes measures to make the drugs available over-the-counter for adult women. The bill, known as the Over-The-Counter Contraceptives Act , would compel FDA to grant suppl...
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    FDA Offers New Guidance on Interpretation of BPCIA

    The US Food and Drug Administration (FDA) on Friday released draft guidance on its interpretation of the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act (BPCIA) of 2010. Put simply: FDA will not approve any pending or tentatively approved application for a biological product under the Federal Food, Drug, and Cosmetic (FD&C) Act after 23 March 2020.  The provision in the BPCIA states that: "An approved application for a biologi...
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    Congressman Says More than 300 Fetal Deaths Related to Essure Ahead of FDA Announcement

    Editor's note: After publishing this article, Focus received comments from Bayer refuting the allegations made by Rep. Fitzpatrick. See our coverage of Bayer's comments in a follow up article published Thursday. Rep. Mike Fitzpatrick (R-PA) on Wednesday presented new information raising questions about the safety of the permanent birth control device Essure, claiming the number of fetal deaths related to the device are far greater than what has been reported by the U...
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    Lawmakers Urge HHS to Exercise 'March-in' Rights to Fight Higher Drug Costs

    A group of 51 lawmakers are calling on the National Institutes of Health (NIH) to issue guidance on when "march-in rights" could be used to bypass patents on drugs developed using federal funding. In a letter led by Rep. Lloyd Doggett (D-TX) to Department of Health and Human Services (HHS) Secretary Sylvia Burwell and NIH Director Francis Collins today, the lawmakers call on NIH to "utilize [its] existing statutory authority to respond to the soaring cost of pharmaceutic...
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    Cruz Calls for Major Overhaul of FDA

    Republican presidential candidate Sen. Ted Cruz (TX) and Sen. Mike Lee (R-Utah) on Friday introduced a bill that would completely overhaul the way the US Food and Drug Administration (FDA) operates. More specifically, the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act (S. 2388), or the RESULT Act,” would: allow for reciprocal approval of drugs, devices and biologics from foreign sponsors in EU member countries, Israel, Australia, Canada and Japan r...