Quality Systems

Articles

Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.

EMA Grants Priority Medicine Status to Cellectar’s Waldenstrom Macroglobulinemia Treatment

Videos

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

Barriers to the Development of Continuous Manufacturing and ICH Q13 (PDA/FDA Joint Regulatory Conference 2023)

Feliza Mirasol is the science editor for 

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

EMA Committee Issues Positive Opinion on Sandoz’ Biosimilar Trastuzumab

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public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

Regulatory Oversight and Compliance