Quality Systems

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

Pharma has voiced strong opposition against Britain’s departure from the EU.

FDA approved Probuphine, the first buprenorphine implant approved in the United States for the treatment of opioid dependence.

The company received a warning letter at its Latina facility in Sermoneta, Italy following a May 2015 inspection.

The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.

Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.

The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.

Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.

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The draft guidance helps companies design new treatments of chronic obstructive pulmonary disease.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