Regulatory Oversight and Compliance

What Goes Wrong When API Quality is Compromised?

August 03, 2022

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

An Integrated Approach to the Data Lifecycle in BioPharma

August 02, 2022

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

Detecting Apparent Total Nitrosamine Content in Pharmaceutical Drugs

August 02, 2022

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

Ensuring API Quality—The EDQM Perspective

August 02, 2022

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

FDA Joins Effort to Curb Drug Patent Abuses

August 02, 2022

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

New Guidance on the Use of Real-World Evidence

August 02, 2022

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

Regulatory Applications for Biologics

August 02, 2022

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

FDA Confirms Ongoing Reliance on Remote Inspection Methods

August 02, 2022

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.

European Commission Approves AbbVie Axial Spondyloarthritis Treatment

August 01, 2022

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

PTC Granted Marketing Authorization by European Commission for AADC Deficiency Treatment

August 01, 2022

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