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  • Regulatory NewsRegulatory News

    FDA to Begin Issuing Deficiency Review Letters to Generic Drugmakers

    The US Food and Drug Administration (FDA) on Friday published draft guidance that would establish a new type of letter the agency sends to generic drugmakers to provide applicants with preliminary thoughts on possible deficiencies of an abbreviated new drug application (ANDA). Thanks to the recently reauthorized Generic Drug User Fee Amendments (GDUFA II), FDA will issue Deficiency Review Letters (DRLs) and information requests (IRs) to obtain further information ...
  • Regulatory NewsRegulatory News

    Updated: Generic Drug Monthly Dashboard: FDA Adds New Metrics

    The US Food and Drug Administration (FDA) last month began releasing new information a monthly basis related to generic drugs. Whereas in previous years, the agency released monthly statistics on 12 different categories related to FDA’s review of abbreviated new drug applications (ANDAs), now the agency releases monthly data on 30 different categories. The new categories will shine a light on metrics where the generics industry has struggled in recent years, like...
  • Regulatory NewsRegulatory News

    FDA Sets Monthly ANDA Records in October

    The US Food and Drug Administration (FDA) in October issued complete responses to 325 abbreviated new drug applications (ANDAs) and approved or tentatively approved 101 ANDAs, the highest numbers in a single month since the enactment of Generic Drug User Fee Amendments ( GDUFA ). FDA approved 87 ANDAs, including seven first-time generic approvals , and granted 14 more tentative ANDA approvals The figures come from FDA's first monthly performance report for its generi...
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    FDA Expands Generic Drug Priority Reviews

    Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever – a trend likely to continue. The progress comes as US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday indicated that the agency will expand which abbreviated new drug applications (ANDA) will see priority reviews. "Earlier this year we made changes to how we pri...
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    FDA Revises Priority ANDA Draft Guidance

    The US Food and Drug Administration (FDA) on Friday issued a revised version of its draft guidance on the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA). As part of the negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA II), FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a pre-submission facility correspondence (PFC) at leas...
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    FDA Drafts Guidance on Controlled Correspondence Under GDUFA II

    The US Food and Drug Administration (FDA) on Thursday released draft guidance on the agency’s new commitments related to controlled correspondence under the recently reauthorized Generic Drug User Fee Amendments (GDUFA II). When finalized, the 20-page guidance will replace guidance from September 2015 from GDUFA I. The GDUFA II commitment letter defines complex controlled correspondence as correspondence related to: Evaluation of clinical content Review of bioe...
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    FDA Describes New GDUFA II User Fee Structure

    The US Food and Drug Administration (FDA) on Friday issued a draft guidance describing the new fee structure and types of fees applicable to generic drugmakers under the recently reauthorized Generic Drug User Fee Amendments (GDUFA II). Specifically, the guidance provides details on the various types of user fees under GDUFA II, how companies can pay those fees, the consequences of not paying and who is responsible for paying them. The guidance also provides informatio...
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    REMS Format and Content: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics. The 34-page draft revises 2009 draft guidance for industry known as, "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications." FDA notes at the outs...
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    Status Updates for ANDAs: FDA Spells Out GDUFA II Provision

    Under the second iteration of the Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) has agreed to provide timely abbreviated new drug application (ANDA) review status updates for all pending ANDAs. The updates for applicants on their ANDA review status will include the issuance of Information Requests (IRs) and Discipline Review Letters (DRLs), and to provide applicants with an advance notification of regulatory correspondence, includ...
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    Another Record Year for US Generic Drug Approvals in 2017

    The US Food and Drug Administration (FDA) has approved more abbreviated new drug application (ANDA) in 2017 than any other year, according to the latest FY 2017 activities report. The 763 approvals (or 927 approvals and tentative approvals) is 112 more generic approvals than last year , which set the previous record for the highest tally in a year, and 271 more than 2015 and 354 more than in 2014 . And unlike in 2016, when FDA issued a vastly higher number of ...
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    Some FDA Medical Device, Generic Drug User Fees Spike in FY 2018

    Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) and Medical Device User Fee Amendments of 2017 (MDUFA IV), the US Food and Drug Administration (FDA) will collect significantly higher user fees for some applications than in recent years though how the fees are calculated has been restructured under the two new agreements. For instance, device companies submitting 510(k) applications, which are for devices equivalent to ones already marketed, fees wi...
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    FDA to Revise Pre-Submission Draft Guidance Due to GDUFA II

    Now that the FDA Reauthorization Act of 2017 (FDARA) is law, the US Food and Drug Administration (FDA) said Tuesday it will revise previously issued draft guidance on the pre-submission of certain information for abbreviated new drug applications (ANDAs). FDARA, which was signed by President Donald Trump last Friday , includes statutory provisions that will expedite the review of qualifying ANDAs by allowing the “pre-submission” of certain information prior to s...