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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
The FDA has approved an sNDA for Novartis’ Promacta for the treatment of children six years and older with the chronic immune thrombocytopenia who have had a poor response to corticosteroids, immunoglobulins or spleen removal. 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
An FDA associate commissioner and five associates are pushing for greater transparency around complete response letters issued to drugmakers when marketing applications are denied. 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
The percentage of drug adverse event assessments leading to updated patient safety information in the EU nearly doubled between 2013 and 2014, from about 20 percent to 40 percent, a new report by the European Medicines Agency shows. Read More
Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More
A UK-funded report is calling for drugmakers and regulators to create 15 new antibiotics every 10 years, at least four of them breakthrough products, to fight the rise in antibiotic resistant bacteria. Read More
India’s drugs price regulator is warning drugmakers that they’ll face fines and imprisonment if they don’t register immediately on an online database. Read More