Quality Systems

Unpacking COVID-19 Pandemic Response

August 10, 2023

Highlights from a wide ranging discussion on COVID-19 pandemic response from Kate Broderick, Chief Innovation Officer at Maravai LifeSciences, and Tom Madden, President & CEO at Acuitas Therapeutics.

FDA Grants Orphan Drug Designation to Treatment of Malignant Glioma

August 08, 2023

The investigational drug was developed to activate a novel uptake pathway, allowing antineoplastic drugs to combat solid tumors more successfully.

FDA Warns that Tydemy May Have Reduced Effectiveness

August 08, 2023

Lower levels of an active ingredient may result in unexpected pregnancies.

Quality Quartets in Risk-Based Qualification: ICH Q9(R1) Considerations

August 03, 2023

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

An Intelligent Drug Development Paradigm

August 03, 2023

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

Progressing Finished Product Inspection Through Automation

August 02, 2023

The industry is taking steps to automate the final product inspection process for complex therapeutics.

Ensuring OSD Quality and Safety

August 02, 2023

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

Phasing Out COVID-19 Regulatory Flexibilities

August 02, 2023

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Industry Challenges Medicare Price Negotiation Scheme

August 02, 2023

Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.

Sharing Critical Information for the Best Outcome

August 02, 2023

The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.