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    Pharma groups question enhanced approach in Q14, call for more alignment between Q14 and Q2(R2)

    Pharmaceutical industry groups praised certain aspects of the International Council for Harmonisation (ICH) draft Q14 and Q2(R2) guidelines yet had questions on how enhanced knowledge on analytical methods should be conveyed in regulatory submissions and whether smaller companies would have the necessary resources to invest in the enhanced approach in Q14.   Other groups had questions related to the use of multivariate modeling in analytical method development. In addi...
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    USP seeks input on mRNA analytical testing guide

    The United States Pharmacopoeia (USP) has released a new draft chapter proposing a set of analytical procedures and best practices to accelerate product development and support quality assessments for mRNA-based vaccines and other therapies, such as treatments for cystic fibrosis and certain cancers.   USP and global stakeholders have “identified a need for analytical procedures and best practices to support the assessment of common quality attributes of mRNA vaccine...
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    MHRA Consults on Analytical Quality by Design Principles

    The UK’s Medicines and Health care products Regulatory Agency (MHRA) on Tuesday opened a three-month public consultation on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeial standards.   “Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management,” MHRA writes.   Th...
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    Evaluating Analytical Similarity: Stakeholders Raise Questions With FDA Draft Guidance

    Biopharma companies and industry groups, including Pfizer, Genentech, Boehringer Ingelheim and the Biosimilars Council, have raised detailed questions in recently released comments on the US Food and Drug Administration’s (FDA) draft guidance on statistical approaches to evaluate analytical similarities for biosimilars. Back in September, FDA released the 15-page draft guidance on the type of information sponsors should obtain about the structural/physicochemical...
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    FDA Offers Draft Guidance on Statistical Approaches to Evaluating Similarity for Biosimilars

    The US Food and Drug Administration (FDA) on Thursday released another piece of the biosimilars puzzle for industry, offering new draft guidance on the type of information a sponsor should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan and the statistical approaches recommended for evaluating analytical similarity. The 15-pag...
  • New Guidance Provides Framework on How to Keep a Drug the Same over Time

    A new draft guidance document released by the US Food and Drug Administration (FDA) is meant to clarify the analytical procedures and methods used to validate the production of drugs and biological products. Background The guidance was last issued in final form in 1987-26 years ago-and in draft form in 2000. Validation procedures and methods are important in the production of pharmaceutical products because they allow a company and regulators to say, with certainty, th...
  • Regulators Say Contract Analytical Company 'Falsified' Testing

    Canadian regulators are scrambling to re-evaluate more than 20 companies' approved and pending products after finding "falsified" testing results during the course of an inspection at Ontario-based Chemi Pharmaceutical, regulators announced on 4 December 2012. In a statement, Health Canada said it is in the process of "verifying the nature and use of testing done by Chemi Pharmaceutical with the company's customers." "Our survey of clients to date indicated that only a ...