OR WAIT null SECS
September 16, 2016
The agency recommended approval of 11 drugs, including three cancer drugs, in September.
The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.
The agency has recommended marketing authorization for Ibrance in the European Union.
September 14, 2016
The agency provides a qualified context of use for the biomarker plasma fibrinogen.
September 02, 2016
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?
The authors of "Common Deficiencies in ANDAs for Dermatologic Drug Products" provide some examples of commonly cited deficiencies cited by FDA.
August 31, 2016
Sandoz won FDA approval for its biosimilar version of Enbrel.
August 29, 2016
The new guidance addresses FDA refuse-to-receive decisions in regards to impurity limits.