• Regulatory NewsRegulatory News

    To speed drug development, ICH proposes reducing rat carcinogenicity testing

    The International Council for Harmonisation (ICH) recently announced a new draft guideline that proposes a “weight of evidence” approach to inform whether a two-year rat study would add value in evaluating a drug’s carcinogenic risks.   The proposed guideline provides more detailed guidance for drug developers who are considering whether rodent studies are needed to assess carcinogenicity. The ICH S1B(R1) addendum, once adopted, should be used in conjunction with the I...
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    Shuren and Stenzel: Bending the arc of testing for COVID – and beyond

    The U.S. Food and Drug Administration’s efforts to rapidly authorize point-of-care and at-home tests during the COVID-19 pandemic could offer a roadmap for a broad effort to bring diagnostic and screening tests to homes and remote locations for a variety of diseases. “The development and authorization of COVID-19 [point-of-care] and at-home tests has been remarkable; a process that can often take more than a year took only a few months in many cases. We believe that les...
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    FDA FY2021 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program:   FDA User Fee Table FY2021 Prescription Drug User Fee Act (PDUFA VI) FY2021 FY2020 Change Applications:            Requiring clinical data $2,875,842 $2,942,965 -$67,123 ...
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    PDUFA VII: FDA and industry set priorities in first round of negotiations

    After kicking off the Prescription Drug User Fee Act (PDUFA) reauthorization process in July, the US Food and Drug Administration (FDA) has released the first set of meeting summaries in its ongoing negotiations with industry that will shape its prescription drug review program from FY2023-2027.   The meeting summaries, while brief, provide insights into what FDA and industry hope to get out of the multi-billion-dollar agreement, with representatives from government ...
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    FDA Warns Chinese Drug Testing Facility for Refusing Inspection

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent in August to China-based drug testing facility Shanghai Institute of Pharmaceutical Industry for refusing an inspection. FDA had planned a surveillance and pre-approval inspection of the facility from 29 November to 4 December 2018, but the company told FDA’s China office in a written response that it was refusing the inspection. "Under section 501(j) of the Federal Food, Drug, and Co...
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    EMA Offers Q&A on Exemptions From Batch Re-Testing for Imported ATMPs

    The question and answer (Q&A) document released by the European Medicines Agency (EMA) on Wednesday describes when an exemption from EU batch re-testing can be granted for imported advanced therapy medicinal products (ATMPs). The three-page Q&A begins by noting that a Qualified Person (QP) has to ensure each batch of imported ATMP is re-tested upon importation. But the QP can certify that the imported batch relies on controls conducted in a third country if the product ...
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    Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars

    The European Medicines Agency (EMA) and European Directorate for the Quality of Medicines and Healthcare (EDQM) on Thursday released a report detailing findings from EMA’s drug sampling and testing program over the last 20 years.   EMA says it plans to extend the program to include biosimilars and that it will expand the generic sampling and testing program first launched in 2011 to include products authorized via the mutual recognition and decentralized procedures. ...
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    Vanda Pharmaceuticals Sues FDA Over Partial Clinical Hold

    In a complaint filed against the US Food and Drug Administration (FDA), Vanda Pharmaceuticals called on a federal district court to lift a partial clinical hold on its experimental drug tradipitant. The complaint—filed with US District Court for the District of Columbia on Tuesday—alleged that FDA acted in violation of the Administrative Procedure Act of 1946 (APA) in imposing the partial clinical hold last December. The hold was imposed on a protocol for a new clinic...
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    Dissolution Testing: British Pharmacopoeia Responds to Consultation

    The British Pharmacopoeia on Monday released its response to its consultation on dissolution testing and announced its plans to update its approach within its product monographs.   The British Pharmacopoeia first launched the consultation in January 2017 to gather input from stakeholders on ways the pharmacopoeia could improve its approach to dissolution testing in its finished product monographs.   Dissolution testing is performed for solid oral drugs to determi...
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    EMA Updates on 3Rs Guideline Review

    The European Medicines Agency (EMA) on Tuesday published a report on actions taken to update its guidelines following a review of 3Rs, or replacement, reduction and refinement, principles to reduce the need for animal testing of medicinal products.   In 2014, EMA’s Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP) launched a review to update their guidelines to ensure they align with 3Rs best practices....
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    One-Time Marketing Status Reports Due in February, FDA Says

    The US Food and Drug Administration (FDA) is calling on all new drug application (NDA) and abbreviated new drug application (ANDA) holders to submit one-time written reports on whether their products are available for sale or if they have been withdrawn or were never made available for sale. Reports are due 14 February and are required under a provision from the law reauthorizing the user fee programs. "The NDA or ANDA holder can submit the one-time report to FDA ...
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    Formal Meetings Between FDA and Biopharma Companies: New Draft Guidance

    Know the difference between a Type A, Type B and Type C meeting with the US Food and Drug Administration (FDA)? New draft guidance released last week will help biopharma companies understand how to conduct such meetings and what to expect. The 20-page draft explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/videoconference meetings or written responses only, what sponsors should include in that request, how F...