After issuing an import alert last year for an IPCA Laboratories API plant in India where employees had been falsifying drug testing results and deleting failed tests, the FDA began looking at its operations further upstream and has now banned products from two of IPCA's finished product facilities.
With Sun Pharmaceutical's $4 billion buyout of Ranbaxy Laboratories all but wrapped up, the combined company has plenty on its plate: get plants banned by the FDA in order, get more products approved and to the market and find $250 million in savings with minimal layoffs.
Wockhardt's U.S. affiliate must face a mass of suits in a state court over its generic version of the acid reflux drug Reglan (metoclopramide), developed by Wyeth before the firm was bought by Pfizer.
Almost 10,000 GE and Siemens MRI machines are being recalled, FDA's database shows. The agency classified the recalls in its second-most severe category, meaning the affected machines "may cause temporary or medically reversible adverse health consequences."
Opinions are all over the map when it comes to whether the FDA regulates medical devices too strictly or too loosely. Those favoring more regulation point to power morcellators and duodenoscopes. Industry and others who favor faster access note that in Europe, many advanced devices are made available years before they are commercialized in the U.S.
Having faced years of criticism for its failure to publish guidelines on how the industry can use social media, the FDA is now being chastised by the advocacy group Union of Concerned Scientists over its lack of a policy for its staff.
The FDA is rushing to complete guidance on abuse-deterrent opioids before the end of June because if it doesn't, Congress has promised to take away $20 million in money for salaries and expenses in the FDA Commissioner's Office and give it instead to its criminal investigations unit to fight drug diversion.
The FDA is putting robot assisted surgery in the spotlight this summer.
Celiac sufferer Michael Weber is suing the FDA for dragging its feet on a citizen petition he filed in 2008. The lawsuit attempts to force the FDA to either ban gluten from use in drugs or at least require labels to indicate it is an ingredient in prescription and over-the-counter drugs.
India's Wockhardt and Granules India each reported surviving a U.S. FDA inspection without any problems being cited.