The FDA may have been all smiles and pleasantries at a recent meeting with its counterparts in India, but that hasn't stopped it from taking serious action against the country's manufacturing plants.
Underwriters Laboratories will train 60 food-and-drug inspectors for India's Gujarat state government so that they begin to assess drug manufacturing plants in the same way that U.S. FDA inspectors do.
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.