• Regulatory NewsRegulatory News

    FDA’s inspection backlog: GAO raises concerns as delays mount

    For decades, the Government Accountability Office (GAO) has raised concerns about the US Food and Drug Administration’s (FDA) inspections program. Now, a year after the agency halted most of its foreign and domestic inspections due to the COVID-19 pandemic, GAO warns that the ensuing backlog could take years to clear.   In a new report and testimony before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related...
  • Regulatory NewsRegulatory News

    FDA Plots Elimination of the Orphan Drug Designation Request Backlog

    With a flood of new orphan drug designation requests, the US Food and Drug Administration (FDA) on Thursday released its new plan to eliminate the backlog of requests in 90 days and to respond to 100% of all new orphan drug designation requests within 90 days. In 2016, the Office of Orphan Products Development (OOPD) received 568 new requests for designation – more than double the number of requests received in 2012. According to FDA’s database of 4,174 orphan d...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Starts Accepting Priority Review Notifications, Implements Revised Orphan Drug Program The Therapeutic Goods Administration (TGA) of Australia has opened its priority review pathway. TGA is now accepting notifications from sponsors who plan to apply for priority review status to accelerate the approval of their medicines in the coming months. Officials at TGA are ...
  • Regulatory NewsRegulatory News

    Main Challenge for Generic Drugmakers? First Cycle Approvals, FDA Says

    The biggest outstanding challenge for the generic drug industry moving into the second iteration of its user fee agreement is multiple cycle reviews before approval, Kathleen Uhl, director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs told participants Tuesday at a generic drugs forum for small businesses. According to FDA’s latest complete set of data, only 9% of abbreviated new drug applications (ANDAs) won approval in the first review cycle, ...
  • Regulatory NewsRegulatory News

    FDA Continues to Reduce Generic Drug Backlog

    The US Food and Drug Administration (FDA) on Wednesday revealed that it approved more than 700 abbreviated new drug applications (ANDAs) for generic drugs in 2016, though the number of ANDAs pending an industry response also rose by more than 700. According to the most recent generic drug review dashboard , the number of ANDAs filed with no communications yet from FDA also fell from 581 ANDAs as of 1 January 2016 to 351 ANDAs as of 1 January 2017. The dashboard s...
  • Regulatory NewsRegulatory News

    Generic Drug Backlog at FDA: A Dive Into the Confusing Numbers

    As the debate over skyrocketing drug prices continues, at least one solution has cropped up in nearly every conversation: Reduce the generic drug backlog at the US Food and Drug Administration (FDA), create more competition and drug prices will come down. But is the generic drug backlog, also known as the abbreviated new drug application (ANDA) backlog, that big of a problem? Or is confusion over what exactly this backlog means and how long it takes FDA to approve gener...
  • Regulatory NewsRegulatory News

    GDUFA II: FDA Looks to Speed Up Generic Drug Approval Process

    On 21 October, the US Food and Drug Administration (FDA) will meet to discuss plans for the second iteration of the Generic Drug User Fee Act (GDUFA II) under which FDA says it will begin offering eight-month and 10-month reviews of abbreviated new drug applications (ANDAs) between 2018 and 2022. The speed at which FDA reviews and approves ANDAs has been a hot topic lately, particularly as at least 315 generics have doubled in price since 2010 and many of those seein...
  • Regulatory NewsRegulatory News

    FDA Continues Steady Reduction of Generic Drug Application Backlog

    As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US Food and Drug Administration (FDA) is speeding the approval of new generic drugs, according to the latest update to the agency’s in-depth look at the backlog of abbreviated new drug applications (ANDAs). The new data (up to 1 July 2016) reveals that FDA has reduced its ANDA workload by about 500 applications in the first six months of 2016 (the ANDA dashboard recapping 2...
  • Regulatory NewsRegulatory News

    Woodcock: FDA Hits ANDA Backlog Reduction Goal Ahead of Schedule

    Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported on Monday via email that as of 1 July 2016, CDER has acted on more than 90 percent of the Generic Drug User Fee Amendments (GDUFA) backlog, thereby accomplishing the agency’s backlog commitment more than one year ahead of schedule.  Under the $1.5 billion GDUFA, which allows generic drug companies to pay user fees to FDA for a more consis...
  • Regulatory NewsRegulatory News

    FDA Slowly Chips Away at ANDA Backlog

    Although the total workload of abbreviated new drug applications (ANDAs) continues to rise, the number of ANDAs currently with the US Food and Drug Administration (FDA) has declined by about 160 ANDAs over the past three months, according the agency’s second generic drug review dashboard released on Monday. The latest data, covering the period from January through March 2016, shows that the number of ANDAs pending filing review has declined from 211 ANDAs as of 1 Janua...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Generic Drug Review Dashboard: FDA Offers a First Look

    As Congress continues to push for the US Food and Drug Administration (FDA) to speed the approval of new generic drugs, which could be key for keeping pharmaceutical prices in check, FDA for the first time is offering an in-depth look at where it stands with industry’s abbreviated new drug applications (ANDAs). What’s clear from the new data on 2015 is that FDA continues to seek more information or require companies to correct what’s known as an “easily correctible defic...