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  • Regulatory NewsRegulatory News

    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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    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...
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    FDA Announces Streamlined Review Pathway for DTC Genetic Tests

    The US Food and Drug Administration (FDA) on Monday detailed its plans to make it easier for companies developing direct-to-consumer (DTC) genetic health risk (GHR) tests to get those tests on the market. To do so, FDA is proposing a model similar to a pilot for digital health products, by which companies can be pre-certified to market low-risk software-based devices following an assessment of their systems for software design, validation and maintenance. Similarly, F...
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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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    PDUFA VI: FDA Explains User Fee Changes in Draft Guidance

    The US Food and Drug Administration (FDA) has begun implementing the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and on Thursday released draft guidance explaining the new fee structure and types of fees for which industry is responsible. Changes to the fee structure under PDUFA VI mean FDA can collect two types of fees through 2022: human drug application fees (accounting for 20% of the total), collected at the time applications are submitted, and pres...