Wyeth Receives Approvable Letter From the FDA for Lybrel (Finanzen.net)
MADISON, N.J., June 28 /PRNewswire-FirstCall/ -- Wyeth announced today that the U.S. Food and Drug Administration (FDA) issued an approvable letter for Lybrel(TM) (90 microgram levonorgestrel/20 mircrogram ethinyl estradiol tablets), a low dose, continuous, non-cyclic combination oral contraceptive.

US FDA to modernize regulations on clinical trials (PharmaBiz)
The US Food and Drug Administration (FDA) announced a series of new policy and regulatory developments to strengthen the Agency's oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency's approach to bioresearch monitoring as part of the Critical Path Initiative.