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The FDA is planning studies on whether drugmakers are effectively conveying the risks associated with a drug when benefit claims about the drug are made online in character-space-limited communications. Read More
The FDA’s Office of Prescription Drug Promotion is ordering Supernus Pharmaceutical to stop making misleading claims about the use and risks of Oxtellar XR. Read More
An FDA advisory committee has narrowly backed the approval of Cempra’s antibiotic Solithera for the treatment of community-acquired bacterial pneumonia, despite raising concerns about the candidate’s safety profile and study sample size. Read More
Mappel Industria, a Brazil-based company received a warning letter from the FDA due to significant violations of cGMP regulations for finished pharmaceuticals. Read More
A proposal to extend the market exclusivity of new drugs approved in India from four years to 10 is dividing the industry, as some argue that the measure would promote safety and others contend it delays generic competition. Read More