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    FDA Pushes Back Enforcement of UDI Requirements for Class I, Unclassified Devices

    The US Food and Drug Administration (FDA) said Friday that it will delay its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years. A Federal Register notice on guidance released Friday, which FDA said takes effect immediately, said: "FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements under Ag...
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    Device Recalls in 2017: Making Sense of the Numbers

    Each year, the US Food and Drug Administration (FDA) designates anywhere from dozen to hundreds of medical device recalls as Class I, indicating that the risk addressed by the recall could potentially cause serious injury or death. But it can be difficult to quantify the number of device recalls in a year, given the multiple data sources from FDA, including a listing of annual Class I and other significant recalls , a device recalls database and a data dashboard . B...
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    WHO to Craft Essential Diagnostics List

    The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL). The committee said the decision to begin developing such a list, agreed to earlier this month, may initially focus on in vitro diagnostics, with initial proposed priority areas including tuberculosis, malaria, HIV and hepatitis B and C. According to WHO , the list "should expand to other areas including other antimicrobial...
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    WHO Essential Medicines Update Adds Antibiotic use Framework and new HCV & HIV Drugs

    The World Health Organization (WHO) on Tuesday announced updates to its essential medicines list (EML), including new recommendations for antibiotic use and the addition of new drugs to treat hepatitis C, HIV and leukemia. The list, which is intended to serve as a model for the most crucial medicines for ensuring public health, is updated every other year based on recommendations from WHO's Expert Committee on the Selection and Use of Essential Medicines. "These medicin...
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    FDA Identifies More Than 70 Class I Devices Now Exempt From 510(k) Requirements

    As part of its implementation of the 21st Century Cures Act, the US Food and Drug Administration (FDA) on Wednesday released a list of more than 70 Class I medical devices that are now exempt from premarket notification requirements. “FDA’s action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation,” the agency said in a notice. The list includes a range of ...
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    Top Ten Stories From 2016 by Traffic

    Thanks to our readers this year for continuing to tune in on a daily basis. Here’s a rundown of the top 10 stories from 2016, a smorgasbord of randomness based on traffic. Happy holidays and happy reading! Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers : A perennial favorite, this explainer breaks down the latest in the lucrative world of PRVs. Teva Wins FDA Approval for First Viagra Generic, Will Not Launch Until 2017 :...
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    FDA Proposes New Rule on Bulk Substances Used to Compound Drugs

    The US Food and Drug Administration (FDA) on Thursday issued a proposed rule that looks to add six bulk drug substances to a list of such substances that can be used in compounding and to remove four other bulk drug substances that FDA evaluated and should not be included in the list. If the proposed rule is finalized, the six bulk drug substances proposed for inclusion will be the first to be included on what’s known as the 503A bulks list. FDA’s Pharmacy Compoundi...
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    EMA Sets Deadlines for 2016 Type I Variations

    The European Medicines Agency (EMA) on Monday said that marketing authorization holders (MAHs) need to submit any minor changes to drug marketing authorizations, also known as Type IA IN and Type IA variations, for 2016 by 30 November. MAHs are also advised to submit any Type IB variations or groupings of Type IB and Type IA variations in 2016 by 13 December 2016. The deadlines have been set so that EMA can acknowledge the validity of the submissions before the age...
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    FDA Offers First Major Update to ‘Orange Book’ Website

    The US Food and Drug Administration (FDA) on Monday launched an improved web-based version of its publication on drugs approved on the basis of safety and effectiveness, more commonly known as the “Orange Book.” FDA's Orange Book is widely used in the regulatory community (and by doctors) for identifying which drug products are substitutable for one another, while FDA's Purple Book is list of all licensed biologics and biosimilars (the biological equivalent of the phar...
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    EMA to Revise Phase I Trial Guidance, Draft Expected in Late 2016

    The European Medicines Agency (EMA) on Thursday announced plans to update its guidelines on first-in-human (FIH) clinical trials following a trial incident in France last January that left one patient dead and five others hospitalized. The proposed revisions come after EMA launched a review of FIH trials in late May . At the time, EMA said its review would be based largely on the findings of two investigations into the fatal trial, which was conducted by French contra...
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    ANSM Committee Delves Into Nitty-Gritty of Fatal French Phase I Trial

    France’s National Agency for Medicines and Health Products Safety (ANSM) released a report this week outlining how its Temporary Specialist Scientific Committee (TSSC) evaluated what went wrong with a first-in-man clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January. ANSM launched its investigation into the Phase I trial in January, which the contract research organization (CRO) running t...
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    Updated Again: FDA to Pull Singapore Device Firm From Import Alert List

    A subsidiary of Biosensors International, a group of companies developing, manufacturing and marketing medical devices for cardiology and critical care procedures, failed to respond to an inspection request from the US Food and Drug Administration (FDA) and its products were banned from entering the US. However, five days after the company's name was posted on the import alert list, a Biosensors spokesman told  Focus  that the company will be removed from the list aft...