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    Expert: OGD on track to approve more generic drugs in FY2022

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) will most likely approve a higher number of generic drugs in FY2022 compared to the prior year, and the number of generic applications received may continue to exceed OGD’s review capacity, asserted Robert Pollock, a senior advisor with Lachman Consultants.   Pollock, who regularly writes about FDA’s generic approvals, spoke to Regulatory Focus and shared these observations in his recent blog ...
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    FDA official discusses common deficiencies derailing ANDAs

    The US Food and Drug Administration (FDA) rejected a fewer number of abbreviated new drug applications (ANDAs) in FY 2021 through its refuse-to-receive (RTR) mechanism compared to previous years, said Peter Enos, a reviewer with the agency’s Office of Generic Drugs. He attributed the improvement to increased transparency with industry, better filing practices and enhanced communication with applicants.   Enos also addressed how industry can improve their submissions to...
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    Generic drug approvals continued to fall in 2021

    The US Food and Drug Administration (FDA) approved or tentatively approved 776 Abbreviated New Drug Applications (ANDAs) for generic drugs in 2021, continuing a steady decline in generic approvals in recent years.   In calendar year 2020 , FDA approved or tentatively approved 948 ANDAs for generic drugs, which was down from 1,014 in 2019 . The latest figures are part of the FDA’s Office of Generic Drugs (OGD) 2021 Annual Report .   But the agency approved 93 “fi...
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    FDA gives generics updates at DIA town hall

    Officials at the US Food and Drug Administration (FDA) addressed plans to prioritize on-site inspections and gave updates regarding certain new drug applications during a generics-focused virtual town hall convened by the Drug Information Association (DIA) as part of its virtual annual meeting. During the session, regulators also shared post-pandemic learnings, including the importance of international collaborations for generic drug development.   The session inclu...
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    2018 in Generic Drugs: Approvals Shine but Questions Remain on Competition

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) this week released its year in review, highlighting another banner year for approvals and new guidance documents. 2018 was the first year of GDUFA II, during which FDA implemented certain new provisions tied to the program and the FDA Reauthorization Act of 2017 (FDARA), including pre-ANDA meetings, reconsideration requests, one-time marketing status updates to the Orange Book and competitive gen...
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    FDA Names New Office of Generic Drugs Director

    In an email to staff on Tuesday, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced that Sally Choe will take over for Kathleen Uhl as Director of the Office of Generic Drugs (OGD) upon Uhl’s retirement at the end of the month after serving more than 20 years at the agency.   “With more than 18 years of experience in global drug development, Sally is an accomplished leader in both governmen...
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    FY 2016 Generic Approvals by FDA: A New Record Under GDUFA

    The US Food and Drug Administration (FDA) published final Fiscal Year 2016 abbreviated new drug application (ANDA) approvals earlier this month, revealing 651 approvals (though it’s 835 if tentative approvals are included), which was 159 more than the number of approvals for FY 2015 and 242 more than the agency approved in FY 2014 . But that high approval figure for last year also comes as the agency sent more complete response letters (CRLs) than any other year....
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    Former FDA Deputy Director Charged With Insider Trading for Leaking Non-Public Approval Information

    A former Deputy Director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) was charged on Wednesday for providing tips on drug approvals to three hedge fund managers that made tens of millions off of the non-public information. The Securities and Exchange Commission (SEC) announced the charges of insider trading against two hedge fund managers and their source, Gordon Johnston, who worked for a dozen years at FDA and leaked approval in...
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    Generic Drug Approvals Hit New Record in 2015, FDA Report Shows

    • 13 April 2016
    The US Food and Drug Administration (FDA) approved more generic drugs in 2015 than ever before and is on track to meet all of its goals from the Generic Drug User Fee Act of 2012 (GDUFA) by 2017, according to the first annual report from FDA’s Office of Generic Drugs (OGD). More than 700 generic drugs were approved and tentatively approved in 2015, which was the highest figure ever; and in December, FDA granted the highest number of approvals and tentative approvals in...
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    Senator Calls on FDA to Reduce ANDA Backlog

    As soaring drug prices remain in the national spotlight, the US Food and Drug Administration (FDA) needs to do what it can to reduce its backlog of generic drug applications, Sen. David Vitter (R-LA) said in a letter to FDA Acting Commissioner Stephen Ostroff. With 86% of all US prescriptions filled as generics, the backlog of nearly 3,000 Abbreviated New Drug Applications (ANDAs) at FDA's Office of Generic Drugs (OGD) ultimately constrains market competition and makes d...
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    FDA to Approve ANDAs on the Basis of Draft Labeling

    The US Food and Drug Administration (FDA) on Monday said via guidance it will approve Abbreviated New Drug Applications (ANDAs) on the basis of draft labeling. The guidance, which FDA is implementing without prior public comment because the agency says it's a "less burdensome policy that is consistent with public health," clarifies that the Office of Generic Drugs (OGD) will no longer require the submission of final printed labeling (FPL) in order to approve an ANDA. Th...
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    Temporary Reshuffle at FDA's Office of Generic Drugs as Leader Takes Medical Leave

    The US Food and Drug Administration's (FDA) top generic drug regulator, Kathleen "Cook" Uhl, is temporarily stepping down to deal with a serious health issue, FDA has confirmed. Uhl has served as head of OGD for two years, first as acting director starting in March 2013, and then as the office's permanent director in January 2015. Under her leadership, OGD has been implementing huge changes spurred by the passage of the Food and Drug Administration Safety and Innovati...