Featured Pharma Online Editorial

51. A New Year's Resolution Suggestion For The FDA 1/22/2024

    Many pharma/biotech companies have continuing compliance problems when getting inspected by our friends at the FDA. In this article, this industry observer with almost 50 years of experience shares some New Year's resolution wishes for the FDA, and, by extension, industry members can consider the list as the foundation for sustainable quality in your operations.

52. Need To Improve Your Change Management? Regulators Can Help With That 1/12/2024

    The path to successful change management in drug manufacturing can be pocked with bottlenecks. Here are some tactics you can use to avoid them.

53. WHO Guidance Seeks To Reduce Antimicrobials In Pharmaceutical Liquid Waste 1/11/2024
    While most nations have regulations and emission standards regarding industrial waste containing antimicrobials, there is no globally accepted framework. This new WHO guidance seeks to establish an independent, scientifically derived framework for applying targets to manage discharges from antibiotic manufacturing facilities. The public comment period ends Jan. 26, 2024.
54. Is FDA's COVID Container Closure System Guidance Useful Post-Pandemic? 1/9/2024

    The COVID-era guidance is designed to help manufacturers make container closure system changes quickly when facing supply constraints. It may be useful when evaluating risks beyond the pandemic.

55. WHO's 6 Principles For An AI Regulatory Framework For Medical Product Development 12/14/2023

    In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.

56. How Does The GAMP 5 Second Edition Update Look One Year Later? 12/12/2023

    Since ISPE published the GAMP 5 update last year, companies say the flexible approach to computerized system validation is helpful, but the new focus on critical thinking remains a challenge.

57. FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities 12/5/2023

    In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.

58. Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs 11/20/2023

    Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.

59. Your Local Affiliates Want More From Your Global Regulatory Information Management 11/9/2023

    Achieving regulatory excellence depends on a combination of process optimization, effective global systems, high data quality, and better local affiliate collaboration. This article shares key takeaways from new survey results from local offices/affiliates representing 94 countries.

60. FDA Seeks Comment On Quality Considerations For Topical Ophthalmic Drug Products Draft Guidance 11/2/2023

    As a response to recent observations regarding the contamination of eye drops, the FDA published draft guidance titled Quality Considerations for Topical Ophthalmic Drug Products on Oct. 13, 2023. In addition to addressing quality considerations, the guidance also provides recommendations about the CMC documentation. The deadline for submitting public comments is Dec. 12, 2023.