Word: fda
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...been exactly 15 years since the FDA first approved the "female condom," but it still hasn't found its niche, except perhaps in the sex trade. While engineers at Apple have already released the next iteration of the 18-month-old iPhone, a second-generation version of the lady-centric contraceptive still doesn't exist...
...strategy meetings each year, one for the northern hemisphere (in February) and one for the Southern (in September). As soon as the organization announces which influenza subtypes should be targeted by the vaccine, medical labs work furiously to develop a shot. Everything happens on a very tight schedule - the FDA must approve the vaccine by the spring, the vaccine must be in production by August and be ready to be administered in October-December, so that people have enough time to develop an immunity by the time flu season comes around in January. The process doesn't always go smoothly...
While the popular perception of illegal insider trading may be clear-cut - say, a pharmaceutical executive selling stock right before the FDA fails to approve a new drug - the law is substantially less black and white. In 1934 Congress passed the Securities Exchange Act but didn't specifically address the topic of insider trading; it was only in the 1960s that the SEC began to bring cases under the law's antifraud statutes. Toward the end of that decade, courts codified the SEC's actions in case law, locking down the idea that everyone in the marketplace should get roughly...
...heparin disaster goes beyond Baxter, SPL and their suppliers--none of whom have been charged with wrongdoing and all of whom say they are cooperating with regulators to find out where problems arose in the supply chain and why. French pharmaceutical giant Sanofi Aventis told French regulators and the FDA that it too had found and recalled tainted heparin last spring. (Baxter pulled all its heparin from the market last January.) In April, deputy FDA commissioner Janet Woodcock said the agency had traced the contaminated heparin api, which ultimately found its way to companies like Baxter in 11 countries...
Working with Baxter, the FDA devised a test that now identifies OSCS in heparin. The FDA will deploy eight full-time staffers in China, including four inspectors and a senior technical expert in foods, medicines and medical devices. And working with its counterpart agency in Beijing--which FDA commissioner Andrew van Eschenbach acknowledges is primarily responsible for drug safety there--the FDA will now be able to do "more timely" inspections in China. In 2008 the FDA did all of 30 inspections in China...