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Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical ProductsThis study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
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The Link Between Manufacturing and Commercialization in Gene and Cell TherapiesThe highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.
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Worldwide Pharmaceutical Meetings—A Place for SharingWorldwide, meetings take place for several reasons, such as to share new findings, learn about novel technologies, discuss international issues, exchange know-hows, and network, to name a few. While each of these reasons has its significant importance, what really matters in scientific inquiry is progress.
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Optimizing Adaptive Trials: The Role of On-Demand Manufacturing and Derisking in Accelerating Early Clinical Trial SuccessWebinar Date/Time: Wednesday, April 2, 2025 11:00 AM EST
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Strong CMO Relationships Expand Opportunities for Sponsors-Stability testing for clinical trial materials -New services for oral solid dosage forms -Sourcing global clinical trials in the U.S. and Japan
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Industry Perspectives#wpbut {border: 3px solid #245998; border-radius:40px; border-color: #245998; padding: 15px 30px; font-size:15px !important;} #wpbut:hover {background: #15355a; color: #fff !important; transition: .5s;}
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Carbohydrates For InjectionElham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.
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Establishing Limits for Dermal Absorption of Elemental ImpuritiesCurrent guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.
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Data Integrity: Getting Back to BasicsEnsuring data integrity involves effort on an individual and global basis.
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Drug Shortages and Complying with FDA’s 21 CFR 211.110 GuidanceSusan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
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Utilizing Run Rules for Effective Monitoring in ManufacturingTo enable efficient monitoring systems, life-science companies need to effectively apply run rules.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryAn analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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Common Deficiencies in ANDAs for Dermatologic Drug ProductsCompanies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
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Common Deficiencies in ANDAs for Dermatologic Drug ProductsCompanies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryAn analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryAn analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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Regulatory Considerations for Controlled Correspondence Related to Generic Drug ChemistryAn analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
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The Many Varieties Of 'Emerging'While most companies recognise the significance of emerging markets, they struggle to jump the first hurdle in addressing these opportunities: defining the right product.
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Lessons Learned from FDA Inspections of Foreign API FacilitiesA study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)
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Lessons Learned from FDA Inspections of Foreign API FacilitiesA study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)
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Technical Note: The Effect of Alcoholic Beverages on Sustained ReleaseThe authors evaluated the effect of alcoholic beverages on the release profiles of sustained-release dosage forms containing metformin and diclofenac.
