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The FDA released draft guidance on field alert reports, using a Q&A format to outline the responsibilities of drug applicants for FAR submissions. Read More
The FDA released draft guidance outlining the information sponsors should include on the Indications and Usage section of drug and biologics labeling. Read More
The FDA announced that it will take enforcement action against compounders using the unapproved bulk substance cesium chloride, partially granting a December 2017 petition by Public Citizen. Read More
CDER Director Janet Woodcock announced details of two new voluntary programs designed to support improvements in product and process quality and to enhance the agency’s use of quality metrics. Read More
In the wake of hundreds of healthcare fraud arrests by the Justice Department last week, FDA Commissioner Scott Gottlieb promised more inspections of compounding and outsourcing facilities that distribute products without a valid medical need. Read More
Endo Pharmaceuticals has settled with the state of Texas for $13.25 million over allegations of illegal marketing for its drug Lidoderm (lidocaine). Read More
In response to investor concern, the board of Cardinal Health announced on Thursday action it has taken to strengthen its anti-diversion tactics and accountability related to the opioid crisis. Read More
Allergan opened a new front in the intensifying legal fight over the opioid crisis, suing Pfizer last week to cover any damages the former might incur in hundreds of lawsuits against it. Read More
The House Energy and Commerce Committee sent letters to three major pharmaceutical manufacturers demanding information on the role they may have played in helping trigger the opioid epidemic. The action is part of the panel’s probe into potential breakdowns in the drug supply chain. Read More
Medicare and its beneficiaries could save a whopping $2.8 billion on the 20 most commonly prescribed brand name drugs — even when accounting for the 17.5 percent average rebate for the drugs, the study says. Read More
Gottlieb said the program appears to be operating as intended (to make sure prescribers and pharmacists are instructed on the meds’ risks and safe uses), but he cautioned there may be more to be done as “a REMS can achieve functional compliance…but not fully achieve its intended public health purpose.” Read More
Last year, the agency estimated it had around 700 employees and predicted the move from London to Amsterdam would cost about 200 jobs. But it’s now predicting more staff reductions. Read More