We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA must review and improve risk management plans (RMPs) for all controlled substances that could potentially be categorized by the Drug Enforcement Administration (DEA) as schedule II drugs, according to a recent General Accounting Office (GAO) report.
The European Commission (E.C.) this week clarified its rules for the parallel drug trade — a practice that drugmakers say costs the industry $5.6 billion in annual sales.
The Center for Drug Evaluation and Research (CDER) has revised its address for the Central Documents Room for filing Drug Master File (DMF) updates, the center announced recently.
Although the FDA is opposed to the reimportation of prescription drugs and despite announcements from HHS that the Medicare Rx law does not give the secretary the power to approve pilot plans sponsored by municipal governments, the agency continues to meet with state and local officials to clear confusion over the practice.
Generic firm Synthon has settled a patent dispute with GlaxoSmithKline (GSK) that paves the way for Synthon to launch a variation of GSK’s profitable antidepressant Paxil (paroxetine HCl).
Eon Labs last week launched the first generic version of GlaxoSmithKline’s (GSK’s) antidepressant Wellbutrin SR 100-mg strength tablets, a move that triggered a GSK-authorized generic version of the drug marketed by Watson Pharmaceuticals.
Drug companies which have competing preclinical research programs for rare diseases and are looking to merge should look to the FTC’s recent decision to close its investigation into Genzyme’s 2001 acquisition of Novazyme Pharmaceuticals as a possible precedent setting move by the commission.