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    ISPE: Global regulators discuss GMP deficiencies, data integrity, real-world evidence

    The COVID-19 public health emergency has prompted regulators to take a different approach to uncovering data integrity violations in virtual inspections compared to onsite inspections, said an official with Australia’s Therapeutic Goods Administration (TGA). The official also provided an update on the status of the EU’s good manufacturing practice (GMP) guide Annex 1, which addresses the manufacture of sterile medicinal products, at a 24 September panel discussion sponsore...
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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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    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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    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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    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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    Sovaldi Patent Rejected in China Following Third-Party Challenge

    China's patent office has rejected a patent related to Gilead Science's blockbuster hepatitis C (HCV) drug Sovaldi. Background The rejection comes one month after the Initiative for Medicines, Access & Knowledge (I-MAK) filed several patent challenges against Gilead in China. I-MAK has also filed similar challenges in Argentina, Brazil, Russia and Ukraine, all citing Sovaldi's high price as a barrier to access in many middle-income countries where licensed generic ve...
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    FDA Provides New Guidance on Whole Slide Imaging Devices

    New draft guidance issued by the US Food and Drug Administration (FDA) offers a high-level roadmap for developers of digital imaging devices known as digital pathology whole slide imaging devices. As explained by FDA in the guidance and elsewhere on its website, the devices are used to convert analog microscope images into digital images, making it easier to diagnose patients without the use of a microscope. The devices generally consist of a larger system of devices (ca...
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    British Regulators Launching Online Registration System for Low-Risk Devices

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The British Medicines and Healthcare products Regulatory Agency (MHRA), responsible for overseeing the UK’s medical device market, is launching a new online registration system for low-risk devices on 11 February 2015. The new  Devices Online Registration System (DORS)  will facilitate online registration of Class I devices, as well as cu...
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    The Future Will be Regulated: FDA Asks for More Information on Robotic Exoskeleton

    The future is here. The future will be regulated. Those are two possible conclusions from an announcement this week by Ekso Bionics, which said its robotic exoskeleton—intended to help paralyzed patients walk by augmenting their strength—must meet additional regulatory requirements put in place by the US Food and Drug Administration (FDA). At issue is the method in which Ekso Bionics' "wearable bionic suit," Ekso, is supposed to be reviewed by regulators before it is all...
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    DEA Establishes Production Limits for Painkillers, With Some Drugs Set for Big Increases

    US drug regulators have set new production quotas for dozens of controlled substances regulated under the Controlled Substances Act (CSA) , establishing the quantities of the drugs which may be produced in 2015. Quota Adjustments In a 5 September 2014 Federal Register notice , the US Drug Enforcement Administration (DEA), which is charged with setting the quotas, released a list of dozens of schedule I and II controlled substances which will be subject to produc...