Quality Systems

Democrats approve curbs for Medicare plans, but not for commercial drug coverage.

The European Commission has approved AstraZeneca and Merck’s Lynparza (olaparib) as an adjuvant treatment for BRCA-mutated HER2-negative high-risk early breast cancer.

Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

Pharmaceutical Technology spoke with Niamh Lynch, Executive Director, Global Head of Quality, Lonza Small Molecules, Basel about best practices for API quality and the impact of the nitrosamine contamination situation.

A comprehensive understanding of potential material change can mitigate its impact on patient safety.

The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients.

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Successful digital transformation in biopharma requires an integrated approach to the data lifecycle.

Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.

Pharmaceutical Technology Europe spoke with representatives from the European Directorate for the Quality of Medicines & Healthcare (EDQM) about API quality from their perspective.

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.

Pharmaceutical Technology spoke with Ed Gump, VP Small Molecules at the US Pharmacopeia (USP) about API quality from the standards perspective.

Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about biologics license applications.

FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.

How can we fix the quality manufacturing issues that come with product shortages?

The European Commission has approved Rinvoq (upadacitinib) for treatment of active non-radiographic axial spondyloarthritis.

The European Commission has granted marketing authorization to Upstaza (eladocagene exuparvovec) for treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

Scrutiny of accelerated approvals has generated a range of reform proposals to accelerate the conduct of confirmatory studies.

The agency’s human medicines committee recommended drugs to treat breast cancer, lupus nephritis, type 2 diabetes and more.

A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.

Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.

Health Canada has authorized Moderna’s COVID-19 vaccine for use in young children aged six months to five years.

US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.

FDA has granted an Emergency Use Authorization to Novavax’s COVID-19 vaccine.

The European Medicines Agency guidance highlights key principles and examples of good practices to prevent and manage shortages of human medicines.

Exhibitors display innovations for parenteral and solid dose products.

Application for OTC contraceptive highlights efforts to broaden access to medicines.

Some states look to block access to approved drugs.

LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.