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  • Regulatory NewsRegulatory News

    FDA officials address common pitfalls affecting post-approval change applications

    The US Food and Drug Administration (FDA) offered some advice to help ensure smoother reviews of abbreviated new drug application (ANDA) post-approval supplements and addressed how certain changes should be categorized at the 10 November meeting of the Association for Accessible Medicines” (AAM) GRx+Biosim conference.   Officials were asked to address common issues affecting ANDA post-approval chemistry, manufacturing and controls (CMC) submissions. Agency officials ...
  • Feature ArticlesFeature Articles

    Data integrity remediation and cGMP facilities

    Data integrity remediation is a critical activity performed by analytical laboratories, quality control laboratories, and manufacturing plants to comply with good manufacturing practice (GMP) and data integrity requirements. There are various challenges during this activity, and current GMP (cGMP) facilities struggle to comply due to technical limitations and resource constraints. This article examines the data integrity remediation challenges faced by cGMP facilities and ...
  • Regulatory NewsRegulatory News

    FDA officials tout progress and achievements in advanced manufacturing

    The US Food and Drug Administration’s (FDA’S) efforts to encourage the industry’s adoption of advanced manufacturing is bearing fruit, according to a new update from the agency, noting robust interest from industry in participating in the agency’s Emerging Technologies Program (ETP).   In addition, “significant funding” from Congress has helped fund more research in advanced manufacturing, wrote Michael Kopcha, director of the Office of Pharmaceutical Quality in the FD...
  • Regulatory NewsRegulatory News

    FDA extends comment period on ICH Q12 guidance

    The US Food and Drug Administration (FDA) has reopened the comment period on its draft guidance implementing the International Council for Harmonization’s (ICH) Q12 guideline on postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances.   The additional time was requested by the Pharmaceutical Research and Manufacturers of America (PhRMA).   FDA announced in a pre-publication notice in the 8 Septembe...
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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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...