Quality Systems

The company is voluntarily recalling the product due to difficulties with the delivery system.

The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.

Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.

Horizon Europe gains parliamentary endorsement, bringing it closer to becoming a reality.

A new conference is set to provide a platform for European regulatory professionals to come together to discuss relevant issues and share expertise.

Regis Technologies reported that no Form 483 observations were issued following a routine FDA inspection.

The company’s center of excellence for advanced analytical testing passed GMP inspection from the European Medicines Agency.

Lonza’s fully automated plate-based PyroTec PRO Robotic Solution accelerates endotoxin testing of parenteral pharmaceuticals.

CDER Director Janet Woodcock is finalizing this more streamlined approach process for evaluating new drugs to handle the surge in drug application submissions.

The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.

The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.

Sharpless will seek further solutions to the opioid crisis and work to reduce cigarette use in adults and kids.

FDA sent a warning letter to RIJ Pharmaceutical LLC after an inspection of the company’s Middletown, NY facility found CGMP violations.

The agency sent a warning letter to Luen Fook Medicine Sdn., Bhd. for CGMP violations found at the company’s Malaysia facility.

EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.

At INTERPHEX 2019, CEO Richard Johnson highlighted the importance of PDA’s new Asian business unit and outlined the organization’s plans. Data integrity guidance for manufacturing and quality systems will be published by the end of the year, as efforts move into big data and artificial intelligence.

The European Medicines Agency weighs in on the role of regulators in determining added benefits of novel therapies.

FDA Commissioner Scott Gottlieb and Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, expect shortages to ease within six months. Although recycled solvents and materials are a prime concern, questions remain about the sources of contamination.

The agency approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.

The Quartic Platform is a new, AI-powered smart manufacturing platform that can be integrated into legacy facilities and manufacturing processes.

In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.

Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.

A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

FDA is moving to shift industry away from step-wise batch production.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.