Quality Systems

Articles

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

FDA Issues Guidance on Biosimilar Labeling

The safety profile of erdafitinib observed in THOR was consistent with the previously reported safety profile of erdafitinib in metastatic urothelial carcinoma (mUC).

Janssen Submits Marketing Authorization Application to EMA For Approval of Erdafitinib

Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

Rentschler Biopharma ATMP Facility Receives MHRA Approval

The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to in vivo adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.

Charles River and PathoQuest Publish Study Validating Proprietary Next-Generation Sequencing Viral Safety Assay 

The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.

FDA Establishes Stabilization Period for Updated DSCSA Compliance Policies

Further expansions of the pharmaceutical development and manufacturing services of ten23 are happening at the BASE and VIVA facilities to continue to support complex sterile product development, testing, and manufacturing. 

ten23 Expands Sterile Manufacturing Capacity at VIVA 1 Facility 

Adam C. Fisher, Phd, is Director of Science Staff, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

The Future is the Present: Artificial Intelligence in Pharmaceutical Manufacturing

Martin J. Lipa, PhD, martin.lipa@prst.ie, is a senior research fellow at Pharmaceutical Regulatory Science Team.

Anne Greene, PhD, is director PRST, Technological University Dublin.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

Knowledge as the Currency of Managing Risk: A Smart Investment for Patients

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

The ACT EU initiative aims to develop the European Union further as a competitive centre for innovative clinical research.

Accelerating Clinical Trials in the EU

There are many promising trials in the pipeline that may bring big news for major therapeutic areas.

Regulatory Oversight and Compliance