• Regulatory NewsRegulatory News

    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manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report.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through the use of a comparability protocol (CP) should take note of an updated US Food and Drug Administration (FDA) draft guidance released Tuesday.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...
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    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...
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    PhRMA, BIO Call for Global Approach on Regulations Governing Manufacturing Changes

    The US Food and Drug Administration (FDA) should work more closely with the International Conference on Harmonization (ICH) on the reporting of chemistry, manufacturing and controls (CMC) changes for approved drugs and biologics, according to the industry groups’ comments on proposed FDA draft guidance. The FDA draft guidance , known as Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products and released in June, lays out new recommendat...
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    Which Drug Manufacturing Changes Should be Reported? FDA Explains

    New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, and how. Background The draft guidance, Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products , focuses on changes made to chemistry, manufacturing and controls (CMC)—the core components of the drug production process. At the time a drug...
  • FDA Unveils New Guidance on Reporting Post-Approval Changes

    • 04 March 2014
    A new guidance finalized by the US Food and Drug Administration (FDA) is meant to clarify which events and changes sponsors of new and generic drug products need to report in their annual reports to FDA. Under FDA regulations, changes to an approved new drug application (NDA) or abbreviated new drug application (ANDA) must be reported to regulators. Depending on the impact, reports of the change must either be approved in advance (Prior Approval Supplement), reported at ...
  • FDA Releases New Veterinary CMC Guidance

    The US Food and Drug Administration (FDA) is releasing new guidance for industry for chemistry, manufacturing and controls (CMC) information relating to fermentation-derived products, including intermediates, drug substances and related drug products for veterinary medicinal use. The guidance "provides recommendations on what documentation to submit to support the [CMC] information" for veterinary products to the Center for Veterinary Medicine (CVM). "This information i...
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    Demystifying CMC Regulatory Strategy for Biologics - Part 3: An Effective CMC Regulatory Strategy Is Possible

    Note: Demystifying, according to Merriam-Webster's dictionary, is "to remove the mystery or mystique; to make rational or comprehensive." This is the third part of a series on demystifying CMC regulatory strategy for biologics. Part 1 covered the complexity of biologic CMC regulation; 1 Part 2 examined the major differences between biologics and chemical drugs; 2 and Part 4 will examine the challenge of adventitious agent contamination control for biologics. Failures...