Quality Systems

Core functions and those funded by FY 2018 user fees are continuing, and 59% of the Agency’s staffers are being retained.

FDA sent a warning letter to Roche’s Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.

Despite ongoing efforts to address drug shortages, FDA now sees a rise in active shortages and in the duration of supply problems.

Agilent and other partners are funding development of Tapestri, a single-cell sequencing platform designed to help predict cancer relapse in individual patients and show the efficacy of gene-editing experiments.

The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.

Asclemed USA Inc., dba Enovachem Pharmaceuticals is recalling the product due to labeling that incorrectly states that stoppers do not contain latex.

FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.

New FDA guidance developed to identify lapses in data integrity and promote best practices.

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

FDA has approved Truxima (rituximab-abbs), a biosimilar to Roche’s anti-cancer biologic, Rituxan (rituximab).

Integration of two separate chromatography data systems boosts workflow efficiency.

The proposal from the Centers for Medicare and Medicaid Services (CMS) proposes to give plans more flexibility to limit coverage of certain drugs.

A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.

Microbial identity data can be critical for determining contamination sources.

Bio/pharma companies cannot spell success without solving all elements of quality programs.

Success depends on supplier communication and transparency, but it’s up to buyers to demand the right information and to look at the vendor’s overall business goals.

Simplified role-based training can lead to better quality metrics and compliance.

Once described as “throwing processes over the wall,” tech transfer is evolving into close collaboration and communication, as potential problems are considered sooner, and new technology is applied. Joseph Szczesiul, director of technical services for UPM Pharmaceuticals, shares best practices.

Drawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.

EMA’s relocation to Amsterdam and resulting staff losses could severely weaken the agency’s role as a leading medicines regulator.

Three hypothetical analytical target profiles (ATPs) are provided, reflecting the current thinking of the the European Federation of Pharmaceutical Industries and Associations Analytical Lifecycle Management Team.

GMP non-compliance can spill over and impact patient access to life-saving medications.

Owner of Immuno Biotech, David Noakes, has been sentenced to 15 months in prison over charges of manufacturing, selling, and supplying an unlicensed medicine, as well as money laundering.

Five additional European Union member states have been confirmed by the US Food and Drug Administration (FDA) as capable of performing good manufacturing practice inspections at a level equivalent to that of the United Sates

A new, high-throughput microplate reader cuts down on screening time and works faster than standard ultra-high-performance liquid chromatography processes.