FDA issues a guidance explaining GDUFA requirements for holders of Type II API DMFs referenced in ANDAs, PSAs, or amendments to either of them.
The Federal Trade Commission sets an 11/8 workshop on drug market competition with an address by FDA commissioner Scott Gottlieb.
FDA issues a guidance on submitting to prior approval supplements and their amendments to FDA.
Federal Register: FDA announces a 10/20 public workshop on Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improv...
FDA issues a guidance with recommendations for preparing the Common Technical Document for the Registration of Pharmaceuticals for Human Use.
FDA commissioner Scott Gottlieb says the agency is very concerned about 13 sole-sourced drug products that are made in Puerto Rico and could be in sho...
Federal Register notice: FDA announces amendments to an earlier notice that provided details of a 10/11-12 Patient Engagement Advisory Committee meeti...
ClassAction.com says an FDA-mandated postmarket surveillance study of Bayers Essure birth control device has enrolled only one patient of the 2,400 ne...