For the first time, the FDA is publishing a list of the drugs manufactured by registered outsourcing facilities. Source: Drug Industry Daily

PhRMA now supports limiting opioid prescriptions for acute pain to a seven-day supply — down from the traditional 30 — saying excess pills can end up falling into the wrong…

Cloudy water got Indian drugmaker Dr. Reddy’s Laboratories in hot water with the FDA, a Form 483 inspection report shows. Source: Drug Industry Daily

A New York City pharmacy that produces drugs as part of the multibillion-dollar Magellan Health healthcare management corporation was cited in an FDA warning letter for failure to maintain sterile…

A Pennsylvania federal judge dismissed a class-action lawsuit against more than 10 drugmakers that accused them of misrepresenting facts to inflate generic drug prices. Source: Drug Industry Daily

The European Medicines Agency stands to lose nearly one-fifth of its staff when it leaves London, no matter which city in the European Union is selected for its new headquarters,…

The FDA finalized guidance on its process for assigning applications to a specific regulatory center, hoping to answer frequently asked questions from industry sponsors regarding whether their product will be…

Following the destruction brought by Hurricane Maria in Puerto Rico, FDA Commissioner Scott Gottlieb said one of the agency’s main goals in the recovery effort is to bring the island’s…

A federal judge in Nevada set a hearing for Oct. 17 on a move by BIO and PhRMA to block the state’s new law on price transparency for diabetes drugs,…

The Saint Regis Mohawk tribe asked a federal agency to dismiss several challenges of the patents it now holds for Allergan, arguing the tribe is a sovereign nation and immune…