BioPhorum recently published a new document entitled "Restarting the inbound supply chain: a BioPhorum Supply Partnering and Relationship Management position paper".
The Competent Authority of Romania (National Authority Of Medicines And Medical Devices) has issued two new GDP Non-Compliance Reports related to human medicinal products in the EudraGMDP database.
An updated glossary of terms and definitions has been compiled and published by the Council for International Organizations of Medical Sciences (CIOMS) from across ICH Guidelines.
The USP General ChaptersPackaging and Distribution Expert Committee published a revised version of USP's new chapter <383> Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components.
The U.S. Food and Drug Administration (FDA) has recently published a new Warning Letter. The authority observed pest activity in the raw storage area, water leaks, and missing ceiling tiles in the drug manufacturing area. Furthermore, employees used the QC lab for non-CGMP activities, such as meal preparation and dishwashing.
In a Warning Letter dated October 2024, the FDA lists a large number of deficiencies found during an inspection of a manufacturer of cell and tissue products. These ranged from deviations in quality measures to errors in registration or classification under the Federal Food, Drug, and Cosmetic Act or 21 CFR.
On 30 October 2024, the Center for Drug Evaluation and Research within the U.S. Food and Drug Administration has published a Guidance for Industry entitled "M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms". The document is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases.
The European Medicines Agency (EMA) has been conducting a pilot study to explore the benefits of visualizing and analyzing data from clinical studies. The pilot has initially been designed with an estimated duration of two to three years (from September 2022). An interim report is now available analyzing patient-level clinical study data submitted voluntarily by marketing authorization holders.
The FDA issued two draft guidances and one final guidance to support innovative clinical trial approaches. According to the agency, these approaches can increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges.
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.