• Industry, FDA begin to hammer out PDUFA VII details

    Discussions continue between industry and the US Food and Drug Administration (FDA) regarding the upcoming reauthorization of user fees for prescription drugs, biologics and generic drugs. After public hearing and a first round of meetings that gave a peek into priorities for industry and regulator representatives, this next round began to sort out some detail. (RELATED: PDUFA VII: FDA and industry set priorities in first round of negotiations , Regulatory Focus 29 Octo...
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    GDUFA III negotiations turn to FDA financials

    Representatives from the generics drug industry are refining priorities in their ongoing negotiations with the US Food and Drug Administration (FDA), as part of the reauthorization process for the Generic Drug User Fee Amendments of 2017 (GDUFA III).   Negotiations for GDUFA III kicked off with a 21 July public hearing and an early set of meetings that set ground rules and found common ground in the importance of increasing the number of first cycle approvals.   Th...
  • Industry-FDA GDUFA III negotiations seek higher first-round approval rates

    Moving on from the kickoff of the 21 July public hearing, the US Food and Drug Administration and representatives of the generics industry have begun substantive negotiations for the terms of reauthorization of the Generic Drug User Fee Amendments of 2017 (GDUFA).   After the first four rounds of negotiations between the US Food and Drug Administration (FDA) and the generics industry, representatives from industry and the FDA have honed in on the pre-facility correspon...
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    Lack of product-specific guidance slows ANDAs: FDA study

    Researchers at the US Food and Drug Administration (FDA) found that, for drugs that are new chemical entities, generic submissions were more likely when the reference brand-name drug generated more revenue.   Looking into other factors that predict that an abbreviated new drug application (ANDA) will be filed for a reference drug, the investigators also found that sponsors were less likely to file ANDAs for complex drugs.   In a retrospective study examining 400 br...
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    FDA clarifies reference-listed drugs, other ANDA terms in final guidance

    Generic drugmakers have received finalized guidance from the US Food and Drug Administration. In finalizing a 2017 draft, the agency gives sponsors of abbreviated new drug applications (ANDAs) information about how to identify reference listed drugs (RLDs), further details on reference standards, and what forms the basis for an ANDA submission.   “The guidance is intended to clarify what these terms mean and how to accurately use these terms in an ANDA,” said FDA in an...
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    Generic drugmakers get revised MAPP for suitability petitions

    A newly revised policy and procedure manual is available to generic drugmakers who wish to submit an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for a formulation that differs in certain ways from the reference listed drug.   The Manual of Policies and Procedures (MAPP) published by FDA’s Office of Generic Drugs lays out how applicants can petition FDA  to submit an ANDA when the generic drug differs from the reference listed dr...
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    Generic drugmakers get guidance on tentative approvals, CRLs

    Generic drug makers received a final and a draft guidance from the US Food and Drug Administration (FDA) on 28 September that address components of the submission process for an abbreviated new drug application (ANDA).   The draft guidance for generic drugmakers seeks to address problems created when a sponsor fails to respond to an ANDA complete response letter (CRL) within the timeframe stipulated by federal regulations.   The three choices an ANDA sponsor has on...
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    ANDA consolidation process updated in new MAPP

    The US Food and Drug Administration (FDA) has updated its manual of policies and procedures (MAPP) for the review of requests to consolidate previously approved generic drug applications.   The revised MAPP , entitled “ Consolidation of ANDAs by the Office of Generic Drugs ,” replaces the original October 2015 version of the document. The revisions clarify the process for sponsors of Abbreviated New Drug Applications (ANDAs) who wish to consolidate several ANDAs for d...
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    FDA kicks off GDUFA III reauthorization process

    In a public meeting held via webcast, officials of the US Food and Drug Administration (FDA) kicked off the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA). The meeting, which included presentations by members of industry and the public, is the first of many that will shape the agency’s third GDUFA program.    GDUFA II, authorized in 2017, expires at the end of September 2022. The GDUFA II agreement had two major objectives in speeding access to ...
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    Grassley Calls for More Unannounced Foreign Drug Inspections From FDA

    As the US Food and Drug Administration (FDA) explores plans to lower the cost of pharmaceuticals with imports from Canada and elsewhere, Sen. Chuck Grassley (R-IA) is calling on the agency to perform more unannounced inspections of foreign facilities. Thanks to recent media coverage (on  China and tainted blood pressure medicines  and another article on  generic drug manufacturing ) as well as a controversial new book on the US reliance on foreign-made generic medicin...
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    House E&C Committee Addresses 7 Bills to Improve Generic Competition

    The House Committee on Energy & Commerce’s health subcommittee on Wednesday held a hearing to discuss seven bills that help generic drug companies gain access to samples for testing necessary to win generic approval, tweak parts of the 180-day exclusivity that first generic filers can win and make updates to the Orange Book of generic drug patents and the Purple Book for biosimilars. All seven bills are part of Congress’ attempt to bring more generic drug competition to...
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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...