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FDA Warning Letter: Unlicensed biological Product, Misbranding and many other Offences

During an inspection, the FDA found serious violations in the manufacture of an amniotic fluid-based product. An official warning letter lists, among other things, the lack of a licence for a medicinal product, violations of good manufacturing practices (CGMP) and misleading labeling - with potentially far-reaching consequences for the company.

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Become a speaker at PharmaLab 2025 - Analytics, Bioanalytics, Microbiology and more

The 13th PharmaLab Congress from November 24-28, 2025 will take place as usual in Neuss/Düsseldorf with two pre-conference workshops and several parallel conferences. As always, it offers you the opportunity to become part of the speaker team and submit a presentation to share your knowledge with colleagues and discuss the respective experiences. So, become part of the team of speakers - and submit your proposal for a presentation via our online form.

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14 Submissions for the Professor Wallhäußer Award for Innovations in GMP and Pharmaceutical Technology 2025

The Professor Wallhäußer Award for Innovations in GMP and Pharmaceutical Technology will once again be presented at the PharmaCongress on 8 and 9 April in Wiesbaden. This year, 14 projects have applied for the award, with topics ranging from optimised technology to AI applications.

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EMA Leitlinie zu Qualitäts-, nichtklinischen und klinischen Anforderungen für Prüfpräparate bei ATMPs

Die Europäische Arzneimittel-Agentur (EMA) hat eine umfassende Leitlinie veröffentlicht, die die Qualitäts-, nichtklinischen und klinischen Anforderungen für Prüfpräparate der fortgeschrittenen Therapien (Advanced Therapy Medicinal Products, ATMPs) in klinischen Studien detailliert beschreibt. Diese Richtlinie dient als wichtiger Leitfaden für Entwickler und Forscher, um die Sicherheit und Wirksamkeit von ATMPs während klinischer Prüfungen sicherzustellen.

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FDA publishes updated Guidance on the accelerated Drug Approval Process for serious Diseases

The U.S. Food and Drug Administration (FDA) has published a new guideline on the accelerated approval process. It is intended to facilitate and accelerate the development and review of new drugs for serious or life-threatening diseases with unmet medical needs.

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Recommendations for determining the Suitability of Donors for human Cells, Tissues and cell-based Products (HCT/Ps)

The U.S. Food and Drug Administration (FDA) has published a guidance document to assist facilities that evaluate donors of human cells, tissues and cell-based products (HCT/Ps). This guidance provides comprehensive recommendations to establish compliance with donor screening and testing requirements.

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EMA Q&A - When is Testing for Endotoxin Masking Effects necessary for biological Products?

The EMA has recently published an update to its question and answer catalog for biological medicinal products. Among other things, it also addresses the question of when endotoxin masking effects must be taken into account for biological products.

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FDA Warning Letter: Missing Licence and other CGMP Violations for Biologicals

The US Food and Drug Administration (FDA) has criticised a manufacturer of biologicals for significant violations of current Good Manufacturing Practices (CGMP) following an inspection. The company is accused of manufacturing and distributing unauthorised biological products.

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Revision of USP chapter <1071> on rapid methods and its effect on other USP chapters

United States Pharmacopoeia publishes an overview of the effects of the revision of Chapter <1071>  “Rapid Microbial Tests for Release of Sterile Short-Life Products: A Risk-Based Approach” on other USP chapters and guidance documents.

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Revision of USP <1032> Design and Development of Biological Assays

USP recently published a draft revision of Chapter <1032> Design and Development of Biological Assays, which will be available for comment until the end of January. This chapter is part of 5 USP chapters that deal with the topic of bioassasys.

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