'1996' starting the modern era of biologics regulation: FDA's elimination of establishment licensure and other changes.

On May 14, 1996, the U.S. Food and Drug Administration (FDA) issued a new regulation eliminating the establishment licensure requirement for certain 'specified' biologics and expanded the definition of 'manufacturer' for biologic products in general. These regulatory changes are a significant change in the history of biologics regulation and are the logical culmination to the FDA's recent efforts to make modern biologics regulation conform to modern biologics technology. This regulation essentially placed modern biologics on an equal regulatory and commercial footing with traditional chemical drug products. Executives, legal counsel of biologics manufacturers, and researchers developing biologics need to review their regulatory strategies and commercial agreements in light of these extraordinary changes.

FDA regulation of biomedical software.

A major problem faced by biomedical software developers and users is the complexity of the regulatory regimes confronting them. Of particular concern is whether, and to what extent, they are regulated by the Food and Drug Administration (FDA) and the consequences of such regulation. Producers, distributors, and users of biomedical software often are unaware that FDA regulates many of these products as medical devices. Developers, vendors, distributors, or users of such software are subject to significant civil and criminal liability for noncompliance. This article explains the current regulatory requirements imposed on computer software developers and users by FDA, biomedical and some proactive strategies for avoiding adverse enforcement.

[Ventricular arrhythmia following thioridazine poisoning]. / Troubles du rythme ventriculaires secondaires à une intoxication par thioridazine.

The authors report a case of acute thioridazine (Melleril) poisoning with manifestations of polymorphous ventricular rhythm disturbances in the form of torsades de pointes, with an impaired conscious level. The opportunity is taken to review the electrocardiographic changes and cardiac complications linked to the quinidine-like effect of Melleril.

Coronary to bronchial artery anastomosis with bronchial steal syndrome demonstrated by thallium-201 myocardial tomoscintigraphy.

A case study is presented in which the bronchial steal syndrome is demonstrated by stress thallium-201 myocardial perfusion imaging. The various aspects of the syndrome are discussed. We conclude that bronchial steal syndrome may provoke severe myocardial ischaemia even in the absence of coronary artery stenosis.

[Late outlet strut fracture of an aortic Björk-Shiley and embolization of the prosthetic disc]. / Fracture tardive de montant externe d'une valve de Björk-Shiley en position aortique et embolie du disque prothétique.

A new case of late fracture of an outlet strut in a convexo-concave Björk-Shiley valve is reported. The fracture occurred 6 years after aortic implantation of the valve and was responsible for aorto-iliac embolization by the prosthetic disc and death of the patient from cardiogenic shock. This not uncommon complication of the Björk-Shiley valve prosthesis is usually ascribed to the relative fragility of its outlet strut welded to the metallic ring and subjected to strong pressures. Although most cases were observed within the first two years of prosthetic valve insertion, and mainly with valves manufactured in 1981 and 1982, our case and a few others demonstrate the possibility of late rupture. Cardiologists must be aware of this possible complication, since in some favourable cases it can be diagnosed at an early stage and the patient's life can be saved by an emergency operation.