It cost an average of $19 million to get new drugs through their pivotal clinical trials and onto the market, a new analysis has found. Source: Drug Industry Daily

The FDA rapped Umicore Argentina for violations relating to its control procedures and equipment calibration, following a May inspection of the API manufacturer’s Buenos Aires facility. Source: Drug Industry Daily

The FDA released two new guidances Monday to help speed reviews of generic drugs and get the products to market more quickly. Source: Drug Industry Daily

Genentech and Boehringer Ingelheim want the FDA to amend or clarify parts of its draft guidance on the use of liquids or soft foods as drug administration vehicles. Source: Drug…

In the latest development in the ongoing saga over Allergan’s transfer of Restasis patents to a Native American tribe, the partners sued Amneal for infringing upon two patents for the…

The EMA’s Committee for Medicinal Products for Human Use recommended 13 drugs for human use at its September meeting. Source: Drug Industry Daily

The Congressional Budget Office (CBO) estimates bipartisan legislation designed to speed generic drugs to market could save the federal government as much as $3.3 billion. Source: Drug Industry Daily

The FDA cited Brazilian OTC drugmaker Pietrobon for multiple violations including testing and equipment problems and poor recordkeeping. Source: Drug Industry Daily

FDA guidance on submitting field alert reports contradicts federal regulations on the time frame for when reports must be submitted, Perrigo and GlaxoSmithKline said in public comments. Source: Drug Industry…

The EMA expanded its investigation of valsartan impurities after a new contaminant was discovered in an Indian manufacturer’s active substance, losartan. Source: Drug Industry Daily