Reversibility of Vasalgel™ male contraceptive in a rabbit model.

Background: Development of a non-hormonal long-acting reversible contraceptive for men could have a significant impact on reducing unintended pregnancies. Vasalgel™ is a high molecular weight polymer consisting of styrene-alt-maleic acid (SMA) dissolved in dimethyl sulfoxide being developed as a reversible male contraceptive device. It forms a hydrogel when implanted into the vasa deferentia, which prevents the passage of sperm.

Azoospermia in rabbits following an intravas injection of Vasalgel ™.

Background: Vasectomy is currently the only long-acting contraceptive option available for men, despite increasing demand and potentially significant positive impacts on human health of additional male contraceptive options. Vasalgel ™ is a high molecular weight hydrogel polymer being developed as a non-hormonal long-acting reversible male contraceptive. Vasalgel consists of styrene-alt-maleic acid dissolved in dimethyl sulfoxide, which is distinct from styrene-alt-maleic anhydride materials previously studied.

'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.

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.

[Ventricular arrhythmia following thioridazine poisoning].

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.