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  • Regulatory NewsRegulatory News

    FDA Raises Concerns With 505(q) Petitions

    In a report to Congress, the US Food and Drug Administration (FDA) took issue with a certain statute that requires FDA to prioritize petitions seeking to delay product approvals above other safety petitions that raise public health concerns. “FDA continues to be concerned that section 505(q) does not discourage the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues,” the agency sa...
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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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    Updated: The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US

    Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years. In September, FDA granted tentative approval for Sanofi’s Admelog (insulin lispro injection), a rapid-acting human insulin analog. On 11 December, Admelog received full approval from FDA. In the EU, howe...
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    When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance

    The US Food and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted. The draft highlights criteria for submitting ANDAs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), petitioned ANDAs under section 505(j)(2)(C) ...
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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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    505(b)(2) Approval Pathway: Not Necessarily Shorter Approval Times

    With a goal of avoiding unnecessary duplication of studies performed on a previously approved drug, the 505(b)(2) pathway allows for a more streamlined development and approval process, but for new drug applications (NDAs), the pathway has not led to shorter approval times, according to a recent analysis conducted by the Tufts Center for the Study of Drug Development. Background Established under the Hatch-Waxman Amendments of 1984 to the Federal Food, Drug, and Cosme...
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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 Reiterates Concerns on Citizen Petitions Delaying Drug Approvals

    Although only one abbreviated new drug application (ANDA) and one 505(b)(2) application were delayed in 2015 because of citizen petitions, the US Food and Drug Administration (FDA) has reiterated its concerns that the petitions do not raise valid scientific issues and are only being used to delay the approval of competing products, according to the Thursday release of the FY 2015 report to Congress on approval delays from citizen petitions. In 2015, FDA notes that it ap...
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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...