The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

  • Regulatory NewsRegulatory News

    FDA officials address 'complete assessments' at DMF workshop

    The US Food and Drug Administration (FDA) held a question-and-answer webinar on 9 April to help the generic drug industry avoid problems with their Type II active pharmaceutical ingredient (API) drug master files (DMFs). Such mishaps can potentially derail the agency’s on-time review of generic drug applications.   The 3-hour webinar covered such topics as fee payments, completeness assessments, impurity assessments, facility identification and selecting starting mater...
  • Regulatory NewsRegulatory News

    FDA withdraws 5 opioid ANDAs for no REMS or reports

    Five generic opioid drugs are being withdrawn from the market by the US Food and Drug Administration (FDA), according to a Federal Register announcement.   The action comes after the holders of the abbreviated new drug applications (ANDAs) “have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS),” wrote FDA in announcing the withdrawal.   T...
  • Regulatory NewsRegulatory News

    OGD’s 2020 approvals, regulatory work kept pace despite COVID-19

    The US Food and Drug Administration (FDA) approved or tentatively approved 948 generic drug applications in 2020, with a significant portion aimed at potential treatments and supportive therapies for patients with COVID-19, according to the annual report from FDA’s Office of Generic Drugs (OGD).   In response to the pandemic, OGD devised a system for identifying generic drugs with the potential to treat COVID-19 and accelerating those assessments, according to OGD’s ...
  • Regulatory NewsRegulatory News

    FDA's user fee reauthorization talks continue

    In ongoing negotiations, representatives from the generics drug industry continued their meetings with US Food and Drug Administration (FDA) representatives to discuss the upcoming reauthorization of the Generic Drug User Fee Amendments of 2017 (GDUFA) program. Additional rounds of meeting were held both before and after the start of the new year.   The meetings are closed to the public, and minutes are sparse on details. However, according to published minutes from ...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...