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  • Regulatory NewsRegulatory News

    Generic Drugs in 2017: FDA on Track for Most Approvals Ever

    A little more than 10 months into Fiscal Year 2017 and the US Food and Drug Administration (FDA) is on pace to break its record for abbreviated new drug application (ANDA) approvals from last year. According to the latest version of the activities report of the generic drug program , FDA has approved 633 generic drugs in FY 2017, which compares with a total of 651 approvals in FY 2016 . Also a positive: complete responses for generic drugs are down significantl...
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    FDA Speeding Generic Drug Approvals: Not Just Lip Service

    May and June 2017 have seen the most generic drug approvals since the US Food and Drug Administration (FDA) began tallying its monthly approvals, lending credence to FDA Commissioner Scott Gottlieb's pledge to speed approvals and lower drug costs. According to the activities report of the generic drug program , FDA approved and tentatively approved 96 generic drugs in May and 100 in June (a level FDA has not seen since December 2015 when 99 generics were approved and...
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    Priority Generic Drug Reviews: New FDA Draft Guidance

    In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II) , the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs. Under GDUFA II, FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate pre-submission facility correspondence (PFC) two months ahead of their a...
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    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, ...
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    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...
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    FDA Draft Guidance Looks to Help Speed New Generics to Market

    The blitz of new US Food and Drug Administration (FDA) guidance (11 draft and final documents in the last three days) continued on Friday with the release of a draft helping to clarify for generic drug companies how to define and use several terms, and new ways to expedite generic approvals. In a shift in direction for the agency, and in order to speed the availability of generics, FDA “now will approve a generic drug for which it has made a final determination that the ...
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    FDA Revises Refuse-to-Receive Guidance for ANDAs

    The second revision of the guidance, unveiled Wednesday, is part of the US Food and Drug Administration’s (FDA) attempt to assist abbreviated new drug application (ANDA) sponsors in understanding what deficiencies may cause FDA to refuse to receive (RTR) an ANDA. The guidance features certain recurrent deficiencies that in FDA’s experience have led to an RTR decision, which FDA says means that an ANDA is “not substantially complete.” The guidance also describes how FDA w...
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    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...
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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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    Final FDA Rule Clarifies Pharma Patent Process With Aim of Reducing Unnecessary Litigation

    With the intent to cut back on the type of litigation that can delay the approval and marketing of generic drugs under 505(b)(2) applications and abbreviated new drug applications (ANDAs), the US Food and Drug Administration (FDA) on Wednesday released a final rule that revises and clarifies its regulations on a number of different parts of the pharmaceutical patent process. The 289-page final rule amends FDA’s regulations to facilitate better compliance with and enforce...
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    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...
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    Impurity Deficiencies: How FDA Can Refuse-to-Receive an ANDA

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance that will assist abbreviated new drug application (ANDA) submitters seeking approval of a new strength of a drug. The guidance, for applicants preparing to submit to FDA ANDAs and prior approval supplements to ANDAs, highlights serious deficiencies in impurity information that may cause FDA to refuse-to-receive (RTR) an ANDA. Specifically, FDA says the deficiencies include: “(1) Failing to provi...