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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...
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    Facing Key Challenges, FDA's Office of Generic Drugs Seeks Deputy Director

    The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), fresh off the appointment of a permanent director last month, is hoping to hire someone to act as the office's second-in-command. In a notice posted to the USA Jobs website this week , OGD, which oversees the regulation of all generic pharmaceutical products in the US, said it is trying to fill an open position for deputy director of OGD. The position would be responsible for helping to plan, m...
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    Generic Drug Industry Gets More Time to Comment on new FDA Regulatory Policies

    The US Food and Drug Administration (FDA) is allowing more time for industry stakeholders and the public to weigh in on whether new regulations or policies are needed to oversee the generic pharmaceutical industry. Background As Focus has previously reported, FDA issued a Federal Register notice in August 2014 announcing that it planned to hold a meeting to discuss the implementation of the Generic Drug User Fee Act (GDUFA) provisions of the Food and Drug Administr...
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    On a Hiring Spree, FDA Hires Almost 1,000 New Generic Drug Regulators

    If you're a regulatory professional whose job includes working with the US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), you might be seeing some new names and faces in your interactions with the agency—about a thousand of them, in fact. In an update last week to FDA staff, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), said OGD had succeeded in hiring 923 new employees as of October 2014. OGD has been on a hiring...
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    After Two-Year Search, FDA's Office of Generic Drugs Hires Permanent Leader

    The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD)—the office charged with overseeing and approving all generic drug products in the US—is finally getting a permanent leader, the agency has confirmed. Filling a Void In an email to FDA staff, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research (CDER), said the agency had decided to hire Kathleen "Cook" Uhl as the permanent director for OGD. Uhl had been serving as acting dire...