• Regulatory NewsRegulatory News

    Canada Intends to Further Restrict Promotion of Opioids

    In an effort to combat Canada's opioid crisis, Health Canada this week said it intends to restrict the marketing and advertising of opioid drugs.   “Evidence suggests that the marketing and advertising of opioids has contributed to increased prescription sales and availability of opioids,” the regulatory authority said . From presentations sponsored by opioid manufacturers at conferences to advertisements published in medical journals, these practices “can take many f...
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    Continuous Glucose Monitors: FDA Grants Pediatric Indication to Medtronic Device, Approves Senseonics System

    The US Food and Drug Administration (FDA) announced late Thursday expanded and new approvals of two diabetes management devices—Medtronic’s MiniMed 670G hybrid closed looped system and Senseonics’ Eversense continuous glucose monitoring (CGM) system.   Both of these CGM systems are designed to measure glucose levels in patients’ body every five minutes using sensors surgically implanted under the skin.   Medtronic’s expanded approval allows for the automated insu...
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    CBER Launches new Program for Early Interaction With Biologics Developers

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) on Friday announced it is launching a new program for early meetings with biologics developers.  The new program, called INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs), replaces CBER's existing pre- pre-investigational new drug (IND) meeting program.  "We know that academic investigators, small and medium enterprises, and sometimes even large co...
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    EMA-FDA: Agencies Want to Strengthen Collaboration

    The European Medicines Agency (EMA) on Friday gave an update on the current and future status of its ongoing collaboration with the US Food and Drug Administration (FDA).  The two agencies have a long history of cooperation in a number of areas, including offering parallel scientific advice to drugmakers, and have collaborated on good clinical practice (GCP) inspections, quality by design and simplifying administrative barriers to improve cross-agency communication.  Mo...
  • ReconRecon

    Recon: White House Proposes Taking the Food out of FDA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US White House proposes a narrowing of FDA’s mission — and a new name ( STAT ) ( Endpoints ) Johnson & Johnson hits the Big Apple with latest JLabs site ( MassDevice ) ( Endpoints ) ( BioSpace ) Bristol-Myers clears another hurdle in Merck lung cancer showdown — but big challenges remain ( Endpoints ) ( PharmaTimes ) ( The Pharma Letter -$) ( Fierce ) Nanobiotix soa...
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    Australia Relaxes Oversight on Some Low Risk Drugs, Devices

    The Australian government has endorsed several regulatory activities aimed at reducing the Therapeutic Goods Administration’s (TGA) oversight on a range of low risk pharmaceuticals and medical devices. The changes to the therapeutic goods framework are based on more than 1,000 submissions to a March 2017 consultation. The consultation was released as part of the government’s response to TGA’s Review of Medicines and Medical Devices Regulation , identifying ways in whic...
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    Public Citizen Calls on FDA to Withdraw Takeda Gout Drug

    Nonprofit advocacy group Public Citizen is calling on the US Food and Drug Administration (FDA) to pull Takeda Pharmaceuticals' gout drug Uloric (febuxostat) from the market after a postmarketing study of the drug found higher rates of fatal cardiovascular events and all-cause mortality in patients taking the drug.   In a citizen petition filed Thursday, Public Citizen writes there is "overwhelming evidence that the serious cardiovascular harms of febuxostat outweigh...
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    PIC/S Adopts New Guidelines on Shared Facilities, Revisions to GMP Guide

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has adopted new guidelines on cross-contamination in shared facilities and implemented revisions to several of the sections in its good manufacturing practices (GMP) guide. Both the guidelines and the revisions are intended to further regulatory harmonization between PIC/S and EU recommendations. They are also both set to enter into force on 1 July 2018. The new PIC/S Aide-Memoire and PIC/S guidelines cover a ...
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    FDA Withdraws Guidance on Biosimilar Analytical Studies

    In response to industry concerns, the US Food and Drug Administration (FDA) on Thursday announced it has withdrawn its draft guidance on evaluating studies used to demonstrate analytical similarity between a biosimilar and reference biologic.   FDA says it plans to reissue the draft guidance after considering changes to the document that will "promote a more efficient pathway for the development of biosimilar products."   "Biosimilars foster competition and can low...
  • ReconRecon

    Recon: Rising Insulin Prices Spark Outrage; Six Biotechs Raise $568M in IPOs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Skyrocketing insulin prices provoke new outrage ( The Hill ) The ‘Right to Try’ Could Cost Dying Patients a Fortune ( Bloomberg ) ( Endpoints ) ( Fierce ) ( STAT ) Novo Nordisk’s ‘sema’ whips Merck’s diabetes drug rival in PhIII as it reaches for best-in-class ranking for GLP-1 group ( Endpoints ) ( Reuters ) ( PBR ) Controversial researcher’s diabe...
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    EU Regulatory Roundup: EU Parliament Think Tank Finds Flaws With Commission's HTA Agenda

    Welcome to our EU Regulatory Roundup, our weekly overview of the top regulatory news in Europe.   Parliament Think Tank Finds Flaws With Commission’s HTA Agenda   The think tank of the European Parliament has found fault with preparations to increase cooperation among health technology assessment (HTA) bodies. The group found an impact assessment from the European Commission failed to present a convincing range of options for how to address the issues created by ...
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    FDA Updates Guidance on User Fee Waivers, Reductions and Refunds

    The US Food and Drug Administration (FDA) on Wednesday issued a revised draft guidance providing recommendations to drugmakers planning to request a waiver or reduction in user fees for drugs and biologics.    The draft guidance updates the agency's 2011 final guidance  User Fee Waivers, Reductions and Refunds for Drug and Biological Products  and details the various types of fee waivers, reductions and refunds offered to industry such as those for pressing public healt...