Quality Systems

FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).

FDA cited BBT Biotech GMBH for failing to comply with current good manufacturing practice in its German API manufacturing facility.

The draft guidance helps companies design new treatments of chronic obstructive pulmonary disease.

The company recalls products due to sterility concerns.

The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.

FDA is advising there may be serious and potentially permanent side effects associated with taking fluoroquinolone antibacterial drugs consistently.

Electrophilic and other reactive compounds, and their precursors, must be measured and removed to ensure patient safety.

In this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means.

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.

Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient.

This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.

Biomedical innovation legislation may stall in 2016.

Drug manufacturing lapses undermine NIH research programs.

The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.

The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.

Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.

The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.

Progress is being made, but work remains to be done. Brian Daleiden, vice president of marketing at TraceLink, discusses the state of the industry, as companies attempt to meet complex, and changing, global requirements.

A federal judge entered an order of permanent injunction against Paul W. Franck, the owner and operator of several compounding pharmacies in Florida.

The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.

As the pharmaceutical industry moves toward continuous manufacturing, new documents are needed to provide flexible guidance that meets the new process requirements.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

Revisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.

Application for Sirdupla Uniformity of Delivered Dose Methodology