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Johnson and Johnson’s guilty plea and $2.2 billion settlement with the U.S. government to resolve off-label marketing claims for its anti-psychotic Risperdal leaves the company with more legal fights ahead of it. Read More
GlaxoSmithKline’s experimental coronary heart disease drug darapladib failed to reduce heart attacks, strokes and major cardiovascular events in a closely watched Phase III clinical trial, deflating some expectations for GSK’s Phase III pipeline. Read More
The FDA says someone hacked into CBER’s online submission system last month and may have put users in danger of having their online personal identity stolen. Read More
Despite a recent ruling by the White House Office of Management and Budget (OMB) that $85 million in already collected fiscal 2013 FDA user fees remain impounded and unavailable for the agency to use, no plans have yet emerged in Congress to free up the funds. Read More
The FDA is expected to approve 34 new drugs this year, down from a record 43 approved in 2012. That drop is expected to be temporary, though, as more drugmakers adjust their pipelines to take advantage of the agency’s breakthrough therapy pathway. Read More
The Department of Justice is investigating a Phase III study of AstraZeneca’s (AZ) heart drug Brilinta, which analysts and experts say could revolve around allegations of data falsification. Read More
Senior European Medicines Agency (EMA) officials are cautioning their peers that when it comes to making regulatory decisions, high levels of risk aversion may do more harm than good. Read More
Drugmakers should establish a company task force of upper management and quality personnel to prevent drug shortages, according to new good practice guidelines developed by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Read More
Certain drug and biologic manufacturers must notify the FDA at least six months before they believe a product may be permanently discontinued or experience an interruption in manufacturing, according to a new proposed rule announced last month. Read More
While the number of FDA inspections of clinical investigators has grown in the last 30 years, the proportion of objectionable findings has dramatically decreased, says a new report. Read More
The FDA plans to shift its focus during facility inspections away from examining documentation, such as standard operating procedures, and place more emphasis on a facility’s operational metrics. Read More