Post-Market Approval Surveillance

Post-market approval surveillance: a call for a more integrated and comprehensive approach.

The availability of new therapies over the past 2 decades has dramatically changed the practice of medicine. The introduction of medical devices has ushered in the era of minimally invasive procedures, thus fundamentally changing many surgical disciplines and creating new sub-specialties. Nowhere has the impact of new device technology been more dramatic than in the discipline of interventional...

Post-market drug surveillance projects developing slowly.

Pharmacovigilance and post-black market surveillance.

Pharmacovigilance can be defined as a set of practices aiming at the detection, understanding and assessment of risks related to the use of drugs in a population, and the prevention of consequential adverse effects. In a narrower sense, the term refers exclusively to postmarket surveillance. This paper briefly outlines how pharmacovigilance has come to play a central role in the regulation of n...

Simplifying post-EVAR surveillance.

Surveillance after endovascular aneurysm repair (EVAR) is costly and a burden for the patient. Imaging is performed to detect stent-graft failure from endoleak or haemodynamic obstruction. Presently, computed tomographic angiography (CTA) is considered the gold standard for post-EVAR surveillance, as it has the potential to visualise most threats to stent-graft durability, such as migration, ki...

Post-Polypectomy Colonoscopy Surveillance

Surveillance is becoming common in the practice of colonoscopy because a large number of patients with colorectal polyps are now being discovered as a result of the increased use of colorectal cancer screening, and particularly because of the dramatic increase in screening colonoscopy. Although the term ‘colorectal polyp’ is not synonymous with colorectal adenoma, two-thirds of colorectal polyp...