Related Experiment Video
Updated: Apr 26, 2026

Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform
Published on: April 12, 2021
Channeling postmarketing patient data into pharmaceutical regulatory systems
Maria D F S Barbosa1, David D Smith2
1CA Consultants, PO Box 3237, Princeton, NJ 08543, USA.
Abstract:
A limited amount of data is typically available to support product license applications. That is further complicated by the need to make some medicines available to patients at key times, using expedited drug approval pathways. In addition, increasing immunogenicity concerns have been paralleled by a myriad of biotherapeutics entering development and/or receiving regulatory approval. Postmarketing patient safety is intrinsically dependent on the correct balance of economics, regulatory oversight and legal and enforcement issues. Here, we discuss the changing landscape of pharmacovigilance, with special emphasis on postmarketing commitments and requirements, megadata analysis, regulatory responsibilities and research opportunities. Challenges and possibilities are illustrated with therapeutic drugs approved for treatment of autoimmune diseases, diabetes, cancer, rare diseases and the resurgence of gene therapy.
More Related Videos
09:00TBase - an Integrated Electronic Health Record and Research Database for Kidney Transplant Recipients
Published on: April 13, 2021
06:55Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
Published on: January 8, 2020
Related Concept Videos
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Drug Regulation
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Dosage Regimens: Partial Pharmacokinetic Parameters
FDA Approved Drugs: Changes to Approved Drugs
Drug Products: Biologics, Biosimilars and Interchangeables