• Regulatory NewsRegulatory News

    CBO: Proposed Medicare pricing plan could curb drug development

    A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.   The Elijah E. Cummings Lower Drug Costs Now Act ( H.R. 3 ), introduced in the 116th Congress during the 2019-2020 legislative session, would require the Secretary of Health and Human Servi...
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    FDA fleshes out models for safe continuous manufacture of therapeutic proteins

    The US Food and Drug Administration (FDA) has issued a new paper  to help shed light on how therapeutic proteins can be produced safely on a continuous manufacturing line.   Continuous manufacturing “is still a novel concept for therapeutic proteins” and more “tangible” examples are needed to implement the program, acknowledged FDA in the report. Further, there are “few published studies” addressing viral inactivation methods for these products.   However, it’s im...
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    ICH releases widely anticipated guidance on continuous manufacturing

    The International Council for Harmonisation (ICH) on Tuesday issued its Q13 guideline on continuous manufacturing, making a draft available for public comment.   The long-awaited draft was soon expected, according to an FDA official who gave an update on the status of the guideline at a 14 July CMC Strategy Forum sponsored by the California Separation Science Society (CASSS). (RELATED: Long-awaited ICH continuous manufacturing guideline coming soon , Regulatory Foc...
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    Long-awaited ICH continuous manufacturing guideline coming soon

    The International Council for Harmonization (ICH) Q13 guideline on continuous manufacturing is expected to be released for public comment soon, as the US pharmaceutical industry continues slow but steady adoption of this mode of manufacturing.   Cyrus Agarabi, a reviewer in FDA’s Office of Biotechnology Products in the Office of Pharmaceutical Quality, updated attendees on the status of the ICH Q13 guideline at the 14 July CMC Strategy Forum sponsored by the California...
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    EMA guidelines highlight changes to IMPs triggering notification to regulators

    The European Medicines Agency (EMA) on 1 July released for public consultation two draft guidelines to help sponsors of investigational medicinal products (IMPs) for new drugs and biologics decide whether manufacturing changes are considered a “substantial modification” needing prior approval.   These guidelines are connected to the EU regulation No. 536/2014 which came into force on 20 June 2014. The regulation defines a “substantial modification” as any change to a...
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    FDA focuses on efforts made to avert drug shortages in 2020

    New drug shortages in the US decreased in 2020, in part because of the US Food and Drug Administration’s (FDA’s) use of enforcement discretion to ensure an uninterrupted supply of critical medical products during the COVID-19 public health crisis.   Yet, the agency’s new drug shortages report to Congress said that while these actions helped avert shortages in the short-term, more work is needed to improve supply chain resiliency.   This report summarizes the agency...
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    EMA consults on ICH S12 guideline, shares comments on PFDD reflection paper

    The European Medicines Agency (EMA) on Thursday opened a public consultation on the International Council for Harmonisation’s (ICH) S12 guideline on nonclinical biodistribution (BD) considerations for gene therapies.   The S12 guideline recently reached Step 2b of the ICH process after being endorsed at the ICH Assembly virtual meeting earlier this month. (RELATED: ICH reports ‘significant milestones’ reached on guidelines ranging from impurity testing to eCTD standa...
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    FDA issues final guidance on CMC postapproval changes for biologics

    The US Food and Drug Administration (FDA) on Monday issued a final guidance to assist manufacturers of biological products in determining which types of changes to their products should be submitted in an annual report and which will require a prior approval supplement, the highest reporting category.   The guidance contains minor changes from a draft issued in December 2017; no reporting changes were switched from the minor to major category. Licensed biological produ...
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    Legislators blast Emergent officials at House hearing

    Members of the US House of Representatives lambasted officials of Emergent BioSolutions for ignoring serious potential contamination and cleanliness problems at their facility, causing millions of COVID-19 vaccine doses to be thrown out.   The House Select Subcommittee on the Coronavirus Crisis, chaired by Rep. James Clyburn (D-SC) along with the House Committee on Oversight and Reform heard testimony from Robert Kramer, president and chief executive officer of Emerge...
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    FDA finds mess of sterility problems at Emergent

    Officials from the US Food and Drug Administration (FDA) urged Emergent BioSolutions to stop producing vaccines until it corrects a litany of unsafe practices at the plant which compromised the quality of products. These problems were identified following a recent inspection of the plant’s facility in Baltimore.   The company was contracted by Johnson & Johnson to manufacture its COVID-19 vaccine but had to throw out 15 million doses recently due to a mix-up of ingredi...
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    FDA pilots program to encourage new drug development tools

    The US Food and Drug Administration (FDA) on Monday announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s existing DDT qualification programs.   The qualification process for DDTs was revamped under the 21 st Century Cures Act and FDA currently offers specific qualification programs for biomarkers, clinical outcome assessments (COAs) and animal models for use under the Anim...
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    An overview of upstream manufacturing process and process controls for biologics drug substance: A cytokine case

    This article provides an overview for writing up the biological drug substance manufacturing process and process controls. The authors provide an example for the manufacturing of biological drugs consisting of a cytokine. They cover several complex manufacturing steps and details expected to be included in Section 3.2.S.2.2 (Description of Manufacturing Process and Process Controls) of the Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Us...