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Generics industry groups told FDA officials during a public meeting Monday that review times and approvals of generic drugs have slipped significantly since implementation of the Generic Drug User Fee Act, and they called for major changes when the program is reauthorized in fiscal 2018. Read More
PhRMA and the Medical Information Working Group want the FDA to clarify its rules around manufacturer promotion of off-label drug use and are using a small drugmaker’s lawsuit against the agency to press their case. Read More
Sponsors of new drugs to treat cardiovascular and metabolic diseases should use a composite of all major cardiovascular events as the primary endpoint in studies to establish CV risk, the European Medicines Agency says. Read More
A citizens advocacy group is accusing the FDA of wrongly expanding the indication of Vanda Pharmaceuticals’ sleep disorder drug Hetlioz by labeling it for use in sighted people. Read More
The U.S. Food and Drug Administration plans to provide guidance by year’s end on naming biosimilars, potentially ending much of the confusion over how the products will be labeled and tracked. Read More
All drug and biologic applications and drug master files must be submitted electronically by May 15, 2017, and all commercial investigational new drug applications one year later, under final guidance from the U.S. Food and Drug Administration. Read More
Sponsors of applications for drugs that are highly soluble in water but not easily absorbed through the intestines can now request waivers of studies proving the drug has a systemic effect or is equivalent to a reference product. Read More