• Regulatory NewsRegulatory News

    FDA to Prioritize Generic Drug Applications for ‘Sole-Source’ Products

    The US Food and Drug Administration (FDA) on Friday announced it will begin prioritizing abbreviated new drug applications (ANDAs) for generic submissions for which there is currently only one manufacturer. The change, which would effectively speed up the review of so-called "sole-source" generic drugs could increase competition, help with drug shortages and may even drive down the cost of expensive generics that have no competition. The change came in the form of an upd...
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    API DMFs for ANDAs: FDA Finalizes Guidance on Completeness Assessments

    The US Food and Drug Administration (FDA)'s final guidance issued on Friday will help the generic drug industry prepare for completeness assessments for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA). The guidance, first released in draft form in 2012 , lays out requirements for how companies will have to pay a DMF fee, which for FY 2016 is $42,170, when fi...
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    Generic Drug Review Dashboard: FDA Offers a First Look

    As Congress continues to push for the US Food and Drug Administration (FDA) to speed the approval of new generic drugs, which could be key for keeping pharmaceutical prices in check, FDA for the first time is offering an in-depth look at where it stands with industry’s abbreviated new drug applications (ANDAs). What’s clear from the new data on 2015 is that FDA continues to seek more information or require companies to correct what’s known as an “easily correctible defic...
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    FDA Offers New Bioequivalence Study Guidance for 31 Generic Drug Ingredients

    To help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval, the US Food and Drug Administration (FDA) has published draft product-specific recommendations for 31 different active pharmaceutical ingredients (APIs) and revised recommendations for 11 APIs. The myriad new draft guidance documents focus on what types of bioequivalence (BE) studies may need to be conduct...
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    GPhA: Congress Needs to Work With FDA to Increase Generic Competition

    The Generic Pharmaceutical Association (GPhA) has offered three key recommendations to Congress on how to work with the US Food and Drug Administration (FDA) to increase generic competition, according to a new report issued Tuesday. ANDA Backlog First, like Hillary Clinton and many others in the past, GPhA is calling on Congress to take action to reduce the backlog of abbreviated new drug applications (ANDAs) awaiting FDA approval. The association says Congress should...
  • New Draft Stability Guidance Calls for Use of ICH Standards

    The US Food and Drug Administration (FDA) has released a new draft guidance document pertaining to stability testing of generic drug products and substances which calls for sponsors to rely on five existing standards promoted by the International Conference on Harmonisation (ICH). Abbreviated New Drug Applications (ANDAs) are commonly used to support generic drug applications under section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) . FDA said it ...
  • OTC Topical Pain Relievers Can Cause Dangerous Reactions, Say Regulators

    Regulators with the US Food and Drug Administration (FDA) have sent out a warning to consumers indicating that over-the-counter topical pain relievers such as BENGAY and Icy Hot have in some cases led to dangerous skin reactions. After receiving numerous reports of consumers suffering mild to severe chemical burns from products containing menthol, methyl salicylate or capsaicin, FDA said it had combed its adverse event reporting databases and found 43 cases in which a ...
  • FDA Moves to Reduce Backlog of ANDAs

    The US Food and Drug Administration (FDA) is moving to clear a massive backlog of abbreviated new drug applications (ANDAs), used by companies looking to market generic versions of FDA-approved products, in advance of new resources expected under a duo of user fee bills expected to be passed by the Congress within the next few months. In a 13 June Federal Register posting, the agency said it wants to disregard any ANDA which it deems to have been abandoned by virtue of...
  • CDER Provides Guidance to FDA Staff on How to Expedite Review of ANDA Supplements

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has issued a new Manual of Policies and Procedures (MAPP) document in which the agency describes to internal staff the guidelines for expediting the review of Abbreviated New Drug Application (ANDA) supplements. FDA's 5240.1: Requests for Expedited Review of Supplements to Approved ANDAs , posted  27 April, describes how ANDA supplement sponsors "may ask FDA to expedite ...
  • New Bioequivalence Recommendations for Popular Drugs Released by FDA

    The US Food and Drug Administration (FDA) released updated draft guidances on bioequivalence (BE) recommendations for numerous popular products. The BE studies are used to support abbreviated new drug applications (ANDAs). The draft guidances, released 25 January, use the processes described in Bioequivalence Recommendations for Specific Products (May, 2007) to formulate the BE recommendations. As a result of that guidance, FDA has released BE recommendations for sev...