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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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Publication of three FDA draft guidelines on donor eligibility for HCT/Ps

The FDA has comprehensively updated its guidelines for ensuring the safety of human cells, tissues and cell-based products (HCT/Ps). With a focus on minimising HIV, HCV and HBV transmission risks, the new guidelines rely on more precise testing procedures and uniform, risk-based donor evaluations. These changes represent progress in quality assurance and infection prevention.

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Revision of USP <1085> "Guidelines on Endotoxin Test"

The USP continues to work on updating its chapters around endotoxin testing and is publishing a proposed revision to Chapter <1085> Guidelines on Endotoxin Test.

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Inadequate Classification leads to Warning Letter

An incorrect classification of a biological product led to a Warning Letter from the FDA, even though there was no CGMP violation.

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Warning Letter for an American Manufacturer of Blood Products

The FDA's inspection of a manufacturer of blood products uncovered significant violations of Current Good Manufacturing Practices (CGMP) for blood and blood components, leading to concerns about the safety, purity, and quality of their products. These violations included inadequate staff training, failure to follow procedures, poor record-keeping, and lack of proper investigation into discrepancies.

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