• Regulatory NewsRegulatory News

    Convergence: Regulatory considerations in advancing gene and cellular therapies

    When developing a regulatory submission for a gene or cellular therapy, it’s essential to keep the basics in mind, such as how to demonstrate the product’s identity, purity, and potency, Haroon Hashmi, PhD, told attendees at RAPS Convergence 2021.   “Even when we think about these complex technologies -- new emerging technologies -- certain regulatory principles always stay in place,” said Hashmi, senior vice president at Ziopharm Oncology, which has developed the Slee...
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    FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations

    A week after finalizing guidance on developing interchangeable biosimilars, the US Food and Drug Administration (FDA) has drafted guidance for biosimilar developers on the use of comparative analytical studies that can be used to assess whether a proposed product is biosimilar to a reference product. The 28-page draft guidance revises a final guidance from 2015 on quality considerations for demonstrating biosimilarity and serves as a replacement for a 2017 draft gui...
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    Bispecific Antibodies: FDA Drafts Guidance for Developers

    With more than two dozen companies developing bispecific antibodies, the next frontier of cancer therapy may well involve these genetically engineered, recombinant antibodies, which is why the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help developers of these products. In explaining why bispecific antibodies could be advantageous, FDA notes that they “can target multiple disease-modifying molecules with one drug, with possible adva...
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    CDER Guidance Agenda for 2019: What’s Coming

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to issue almost 100 new draft and revised draft guidance documents spanning 15 different categories, from biosimilars to clinical pharmacology to drug safety, in 2019. The bulk of the guidance documents are contained in three categories: clinical/medical, pharmaceutical quality/CMC and procedural. The guidance in clinical/medical focuses on specific types of develop...
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    CMC Changes for Biologics: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Thursday released draft guidance intended to help applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). Based on a tiered-reporting system for specific changes, the 43-page draft provides applicants and manufacturers with general...
  • Feature ArticlesFeature Articles

    Preparing for and Managing FDA Inspections

    The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...
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    Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports

    Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes for biologics to be documented in annual reports. The draft guidance notes that under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities or responsible personnel that have a ...
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    FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics

    As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report. "Under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities, o...
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    FDA Looks to Standardize PQ/CMC Data and Terminologies

    The US Food and Drug Administration (FDA) on Monday said it is drafting and seeking comment on the use of standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements for electronic submission. FDA, which is considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling (SPL) document, said the move to standardize PQ/CMC data elements and terminologies will improve the efficiency and quality of th...
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    Grouping Supplements for CMC Changes: FDA Outlines New Policy

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) on Tuesday released a new document outlining how supplements can be grouped together and submitted concurrently for the same chemistry, manufacturing and controls (CMC) changes to multiple approved new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biological license applications (BLAs) submitted by the same applicant. The agency says the goal of its new policy is ...
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    Postapproval CMC Changes: FDA Updates Guidance

    Drug and biologics manufacturers looking to implement a chemistry, manufacturing and controls (CMC) postapproval change through the use of a comparability protocol (CP) should take note of an updated US Food and Drug Administration (FDA) draft guidance released Tuesday. The revised draft provides recommendations to drug manufacturers on implementing CMC postapproval change(s) through the use of a CP. Companies that fall within the scope of this guidance will not have to...
  • Feature ArticlesFeature Articles

    Early Biosimilar Development: A Model for Expeditious Progress to a Phase 3 Trial

    This article discusses biosimilar clinical development and how companies are addressing the clinical development concerns associated with early biosimilar drug development. Introduction The introduction of biological medicines has had a significant impact on the health of patients suffering from many debilitating and life threatening diseases. Biological medicines have dramatically reduced disability for patients with inflammatory diseases, such as rheumatoid arthriti...