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  • Regulatory NewsRegulatory News

    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    Generic drug makers received a final and a draft guidance from the US Food and Drug Administration (FDA) on 28 September that address components of the submission process for an abbreviated new drug application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   The draft guidance for generic drugmakers seeks to address problems created when a sponsor fails to respond to an ANDA complete response letter (CRL) within the timeframe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...
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    Generic Drugs: FDA Releases 74 Product-Specific Guidances

    As part of its push to increase generic competition, the US Food and Drug Administration (FDA) on Friday published 74 product-specific guidances, including 22 new and 52 revised guidances.   Four of the new draft guidances and 45 of the revised guidances are for complex drug products, including 16 products for which there are currently no approved abbreviated new drug applications (ANDAs).   Among the new product-specific guidances is help for companies looking to ...
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    FDA Defends its Efforts to Ensure Generic Drug Quality

    The US Food and Drug Administration (FDA) on Friday sought to quell a series of media reports raising questions with the agency’s declining inspectional work around the globe and concerns with the agency’s oversight of generic drugs. FDA Commissioner Scott Gottlieb and FDA’s Center for Drug Evaluation and Research Director Janet Woodcock wrote in an extended statement that recent press reports inaccurately raised questions with the quality of the US drug supply and wron...
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    FDA Updates List of Brand Name Companies Blocking Generic Applicants

    Back in November 2017, FDA Commissioner Scott Gottlieb called on brand name drug companies to “end the shenanigans” around delaying or restricting generic drug competition. But that call to action has not stopped brand name companies from continuing to pursue at least one gaming tactic, which is refusing to provide samples to competitors looking to bring generic products to market. As part of an effort to deter such a tactic, FDA recently created and updated a list o...
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    Marketing Status Notifications: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Wednesday unveiled new draft guidance to help sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what information they’re now required to share with FDA on the marketing status of their brand and generic drugs. Thanks to the FDA Reauthorization Act of 2017 , drugmakers are required to provide additional information regarding the marketing status of approved drug products, includ...