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    TGA and Health Canada Share Experiences With Mutually Relying on Other Inspectors’ Findings

    Almost a year after the Pharmaceutical Inspection Co-operation Scheme (PIC/S) adopted a new guideline allowing regulators to rely on their peers’ good manufacturing practice (GMP) inspections, Health Canada and Australia’s Therapeutic Goods Administration (TGA) shared some early results. According to the guidance, PIC/S members can use so-called “desktop assessments” to waive GMP inspections because an acceptable level of compliance has been established by another PIC/S...
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    House Committee Proposes 6% Increase in FDA Funding for FY 2020

    The House Appropriations Committee on Wednesday released a draft fiscal year 2020 funding bill for the US Food and Drug Administration (FDA), calling for a $184 million increase in discretionary funding over 2019’s enacted level.   Total funding for FDA, including revenue from user fees, is $5.86 billion, according to the bill. That total is slightly less than the $6.1 billion requested by the Trump Administration for FDA.   “Within this total, the Committee prov...
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    Spring Regulatory Agenda for FDA: What New Rulemakings are Coming

    The US Food and Drug Administration (FDA) on Wednesday published its plans for the latest proposed and final rulemakings for drug and medical device companies, with new proposals related to the Right to Try law, investigational new drug (IND) application reporting requirements and amendments to patent term restoration. First Time Published in Unified Agenda The proposed rulemaking related to the Right to Try Act of 2017 , which cut FDA out of the process of granting...
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    TÜV SÜD Becomes Second NB to be Designated Under EU MDR

    Germany-based TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the second notified body (NB) to be designated and notified under the EU Medical Devices Regulation (MDR), which goes into effect next May. TÜV SÜD is now listed alongside BSI UK, which was the first NB designated last January, in the European Commission’s New Approach Notified and Designated Organisations (NANDO) database. According to MedTech Europe, TÜV SÜD submitted its applicat...
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    Drug Regulators Look to Harmonize How They Tackle Innovation

    The International Coalition of Medicines Regulatory Authorities (ICMRA) recently released a report on how various regulators worldwide are working together to better identify and address future regulatory challenges posed by new categories of therapeutics, like cell and gene therapies, and new tools for drug development, such as artificial intelligence (AI). The report, which is part of a wider effort to reduce duplicative work and increase harmonization among drug regu...
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    FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations

    A week after finalizing guidance on developing interchangeable biosimilars, the US Food and Drug Administration (FDA) has drafted guidance for biosimilar developers on the use of comparative analytical studies that can be used to assess whether a proposed product is biosimilar to a reference product. The 28-page draft guidance revises a final guidance from 2015 on quality considerations for demonstrating biosimilarity and serves as a replacement for a 2017 draft gui...
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    SCOTUS Says Judge, Not Jury, Should Decide Merck Drug Labeling Case

    In cases where state failure-to-warn claims should be dismissed as pre-empted by federal law, the Supreme Court on Monday unanimously ruled that judges, rather than juries, are better equipped to evaluate the nature and scope of an agency’s, such as the US Food and Drug Administration (FDA), determination. While ruling that a lower court should re-assess its decision on the Merck case related to the labeling for a drug’s side effects, the majority opinion also noted: “[...
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    FDA Officials Explain When Litigation Can Impact Drug Safety Signals

    The submission of litigation-associated adverse event reports (LARs) to the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) can have an impact on detecting safety signals, Monica Muñoz and Gerald del Pan of FDA’s Office of Surveillance and Epidemiology wrote recently in a research letter to the journal Drug Safety . The letter came in response to a study in the same journal that found lawyer-submitted reports in FAERS did not meaningful...
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    UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

    In preparation for the future of clinical trials under EU Clinical Trial Regulation 536/2014, the UK has been running a pilot program for a little more than a year to streamline the submission and review process for applications to run Clinical Trials of Investigational Medicinal Products (CTIMPs). Under the pilot, which has been run jointly since April 2018 by the UK’s Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA), a sin...
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    Health Canada Explains Revised Fees for Drugs and Devices

    Following extensive stakeholder engagement, Health Canada announced Thursday its plan to revise the fees paid by pharmaceutical and medical device companies. The plan will be implemented 1 April 2020. Presently, Health Canada recovers 43% of its costs for regulatory activities from industry, while the remaining costs are covered by Canadian taxpayers. But the revised fees will increase that percentage and better align Canada with other jurisdictions, like Australia and ...
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    Reassessing Benefit-Risk: FDA Preps for New Guidance

    US Food and Drug Administration (FDA) and pharmaceutical industry experts gathered Thursday in Silver Spring, MD, to discuss how FDA assesses the benefits and risks of new drugs from the preclinical to postmarket phases. The meeting was conducted as part of FDA preparations in drafting new guidance in FY 2020 on the benefit-risk assessment of new drugs and biologics. Theresa Mullin, associate director for strategic initiatives at FDA’s Center for Drug Evaluation and ...
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    Risk-Based Monitoring: Pfizer and BMS Seek Clarity on FDA Draft Guidance

    Pfizer and Bristol-Myers Squibb (BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring (RBM) of clinical trials. The eight-page RBM draft guidance , released in March, comes in the form of eight questions and answers. It expands on guidance from August 2013, known as “ Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring ,” by providing...