Quality Systems

Articles

A pilot program to explore creation and testing of ePIs in regulatory procedures shows positive results.

Electronic Product Information Moves Forward in Europe

EMA recommended 17 drugs for marketing authorization in December, including treatments for rare heart conditions, anemia, and liver disease.

Several Orphan Drugs Among Medicines Recommended for Approval by EMA in December

The Center for Drug Evaluation and Research’s new center will coordinate and promote use of real-word data in regulatory decisions.

FDA Creates CDER Center for Real-World Evidence Innovation 

With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ensuring a quality product.

Enhancing Quality Through Training

Feliza Mirasol is the science editor for 

The European Commission has approved Novo Holdings' acquisition of Catalent, which includes the related sale of three manufacturing sites to Novo Nordisk, which is also acquiring the Czech Republic manufacturing site of Novavax for $200 million.

Novo Nordisk Gains Manufacturing Sites from Novo Holdings and Novavax while EC Approves Catalent Acquisition

Gary Ritchie, InfraTrac gritchie@infratrac.com, is director of Scientific Affairs at InfraTrac.

Sharon Flank, PhD, sflank@infratrac.com, is CEO at InfraTrac.

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.

Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications

The draft guidance provides information on the agency’s accelerated approval process and criteria for approval.

FDA Releases Guidance on Accelerated Approvals

Cheryl Barton is director of PharmaVision, 

The European Commission has developed a roadmap aimed at reversing the rising trend of cancer across the European Union. 

Advancing the Precision Oncology Agenda in Europe

EXO Biologics and ExoXpert, an EXO Biologics subsidiary, have received GMP certification of a European manufacturing facility for exosomes and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.

Exosomes Field Advances with Milestones Achieved by EXO Biologics and ExoXpert

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Videos

Edwin Stone, Bernard Sagaert, and Khaled Yamout go behind the headlines to discuss what the ongoing measles outbreak in the UK means for pandemic preparedness and anti-vaccination trends; new mRNA approaches; and what Roche’s acquisition of Poseida means for complex cell therapies. 

Regulatory Oversight and Compliance