• Regulatory NewsRegulatory News

    FDA Lowers ANDA Fee Rates for 2017

    Generic drugmakers submitting abbreviated new drug applications (ANDAs) and prior approval supplements (PAS) will see their US Food and Drug Administration (FDA) fee rates drop in 2017, though all other rates, including those for drug master files (DMF) and facility fees will increase when compared to 2016. For FY 2017, the generic drug fee rates are: ANDA ($70,480, down from $76,030 in 2016 ), PAS ($35,240, down from $38,020 in 2016), DMF ($51,140, up from $42,170 in ...
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    Generic Drugs From Four Indian and Chinese Companies Blocked From Entering US

    The US Food and Drug Administration (FDA) on Wednesday added four Chinese and Indian companies to a list of generic drug facilities that are banned from shipping products to the US because they failed to pay fees and meet identification requirements stipulated in the Generic Drug User Fee Amendments of 2012 ( GDUFA ). The companies include China’s Jiangsu ZW Pharmaceuticals Co. Ltd., which received a warning letter in 2015, and Wuxi Kaili Pharmaceutical Company, whi...
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    Strategic Regulatory Considerations for Early Medical Device Consultations with Global Regulatory Authorities

    This article discusses the early consultation process for medical devices in the EU and US and key considerations when planning such a meeting. Developing a Global Strategy for Early Consultations Are you developing an innovative medical device? Does it employ a novel technology? Does it provide novel diagnostic information or therapeutic benefit? Is it a combination or borderline product or a companion diagnostic? Do your plans to demonstrate safety, performance and/...
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    FDA's Final Guidance on Generic Drugmaker Correspondence Addresses Some Industry Concerns

    The US Food and Drug Administration's (FDA) final guidance on controlled correspondence between the agency and the generic drug industry released Monday includes some changes that address industry questions and comments. Background Initially released in August 2014, the draft guidance was the fourth guidance document under the 2012 Generic Drug User Fee Act , and was intended to address formal questions posed to FDA prior to the generic drug review process and to clari...
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    FDA Approving Most New Drugs and Biologics During Their First Review, Report Finds

    The US Food and Drug Administration's (FDA) is now approving more new drugs and biologics during their first review cycles than at any time since at least 2008, a new FDA-commissioned report shows. Background The report , conducted by the Eastern Research Group (ERG) on behalf of FDA, is focused on the fifth iteration of the Prescription Drug User Fee Act (PDUFA) , which was passed in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) . P...
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    India to Formalize Pre-Submission Meetings

    In a move that promises to bring greater clarity to India’s regulatory process for pharmaceutical products, India’s regulator has announced plans to formalize a process for pre-submission meetings (PSMs). In a notice dated 28 January 2015, the Central Drugs Standard Control Organization (CDSCO) laid out proposed steps for the process. Purpose and Precedent PSMs are designed to help companies ensure their drug application submissions conform to legal, regulatory and sc...
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    Guess Which International Medical Device Facilities are Most Likely to be Inspected?

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com Let’s say you have responsibility for international facilities in Germany, China a...
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    FDA System to Keep Track of Drug Manufacturers Nears Completion

    A new guidance published by the US Food and Drug Administration (FDA) establishes a specification by which all drug establishments will be identified under a recently established tracking system. Background Under the  Food and Drug Administration Safety and Innovation Act ( FDASIA )  of 2012, both domestic and foreign facilities whose products are imported into the US are now required to register with FDA. Specifically:  ''During the period beginning on October 1 a...
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    Colgate, Other Generic Companies Hit by FDA for Failure to Pay Facility Fees

    The US Food and Drug Administration (FDA) this week issued an unprecedented four Warning Letters to companies, including the consumer healthcare company Colgate, for failing to pay user fees as part of the Generic Drug User Fee Act (GDUFA). Background The act, passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) , includes requirements that all generic drug facilities must register with FDA and pay an associated user fee meant t...
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    FDA Outlines New Communication Process for Generic Drug Companies

    The US Food and Drug Administration (FDA) is out with its fourth draft guidance document under the 2012 Generic Drug User Fee Act, this time explaining the nuances of how generic drug companies can submit requests for information from the agency. Background GDUFA was passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) , and is modeled off other FDA user fee programs such as the Prescription Drug User Fee Act (PDUFA) and the Med...
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    US, EU Officials in Tangle Over Mutual Reliance on Drug Facility Inspections: Report

    US and EU trade negotiators are reportedly hung-up over how—or if—to rely on the results of one another's regulatory inspections of drug manufacturing facilities, threatening to derail part of the Trans-Atlantic Trade and Investment Partnership (TTIP), The Wall Street Journal reports . At issue, the Journal 's Matthew Dalton writes, is that while the US Food and Drug Administration (FDA) is willing to cooperate closely with the European Medicines Agency (EMA) on drug...
  • Time for Generic Pharma Companies to Re-Identify Themselves, FDA Says

    The US Food and Drug Administration (FDA) is reminding all manufacturers of generic drug products, including active pharmaceutical ingredients used in generic drug manufacturing, that they need to re-register with the agency under the terms of a 2012 law. Background In the lead-up to the 2012 passage of  The Food and Drug Administration Safety and Innovation Act (FDASIA) , FDA regulators highlighted a growing problem: Many generic drug manufacturers were moving the...