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Establishing a pregnancy registry is an extremely useful way of gathering information on drugs effects in pregnant women — information that cannot be obtained through clinical trials, according to an expert speaking at an FDAnews audio conference.
European lawmakers are attempting to encourage pharmaceutical companies to ramp up the development of pediatric drugs through new patent exclusivity provisions, a European drug policy expert says.
European lawmakers are attempting to encourage pharmaceutical companies to ramp up the development of pediatric drugs through new patent exclusivity provisions, a European drug policy expert says.
The FDA has rescinded approval of Par Pharmaceutical's abbreviated new drug application (ANDA) for a generic version of GlaxoSmithKline's (GSK) anti-nausea treatment Zofran ODT.
New River Pharmaceuticals has filed its new drug application (NDA) for NRP104, developed as an abuse-resistant follow-on drug to Shire Pharmaceuticals' attention-deficit/hyperactivity disorder (ADHD) drug Adderall XR.
A group representing Europe’s generic drug industry is criticizing a European Union (EU) proposal that would allow drugmakers to gain an additional six months of patent exclusivity on products that undergo pediatric clinical trials.
FDA pediatric advisers this week will discuss adverse event reporting for a half-dozen drugs, as well as the potential cancer risks for pediatric patients treated with topical dermatological immunosuppressants.
Generic drugmaker Mylan Laboratories last month lost another round in its legal battle to market a generic version of Johnson & Johnson’s (J&J’s) Duragesic transdermal pain patch before J&J’s pediatric exclusivity period ends later this month and the patent on the product expires.