Yes, it's FDA Intern! Strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of Janet Woodcock or even FDA commish Andy von Eschenbach! FDA Intern! Who can change the course of mighty clinical trials, approve drug ads faster than a speeding [...]

An FDA panel of outside medical experts said the agency should raise standards for approving diabetes drugs, a move that could affect the $5 billion-plus diabetes drug market in the U.S.[...]

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will conclude today a two-day meeting to decide whether clinical trials to evaluate cardiovascular risks should be undertaken before the meds are approved or after marketing begins and the drugs are used by the population at large And one non-voting panel member, [...]

Wyeth announced that Bernard Poussot, 56, its president and CEO, has assumed the additional position of chairman of the board. Boehringer Ingelheim GmbH said its chief executive officer, Alessandro Banchi, will retire from his post at the end of the year and Andreas Barner, currently deputy CEO, will replace him. [...]

Symbio LLC has opened a new Phase I clinical unit in Michigan City, IN. Symbio provides clinical trial management, biometrics, consulting, product development and topical formulation development. With the addition of the Phase I Unit, the company can provide Phase I through Phase IV development. The Phase I unit has [...]

Teva announced yesterday that the FDA granted final approval to its ANDA for generic Risperdal (risperidone) tablets, that it was awarded 180-day exclusivity as the first paragraph IV filer for risperidone, and that it immediately commenced a commercial launch. FDA confirmed the final approval in a press release. Risperdal is [...]