The upshot of the guidance is most app makers can continue to push out their products without worrying about FDA regulation. FDA will only step in when apps stray into areas that convert mobile devices into tools the agency traditionally regulates as medical devices.
India is second only behind Canada as a supplier of drugs exported to the U.S, so is key to this country's drug supplies. But a string of recent plant infractions show it also is a country where many drugmakers, including the largest, have shown a total lack of competence in manufacturing products to FDA standards.
FDA officials have a mandate to spur the creation of more medical devices designed for kids, and now regulators have given out $3.5 million in grants to 7 research consortia around the country to spark a greater development effort.
The FDA has selected Altaf Ahmed Lal, an Indian-born Ph.D., to take over management of its expanding operations in India. Lal says collaboration with Indian regulators and drugmakers in the country is key to his plans there but acknowledged that his new position "presents a rather daunting challenge."
So what happens at the FDA in the event of a government shutdown next Tuesday? For now, the agency isn't saying, referring reporters to an OMB statement guiding government agencies to prepare to execute "an orderly shutdown."
Drugmakers have been edging into the mobile app world, but to some companies, it still seems fraught with peril. Well, pharma, you can relax on at least one score: The FDA isn't interested in regulating your apps--most of them at least.
The FDA rolled out final rules to guide companies developing mobile medical apps. They'll exert regulatory control over apps designed to work with a regulated medical device or turn a smartphone/tablet into a de facto medical device.
A lobbying battle is being waged ahead of votes on bills to reign in big operators in the compounding pharmacy niche with pharma on one side and the new breed of compounders on the other. There have been bills introduced into both the House and the Senate that would bring at least some of the larger compounders under FDA control, with the Senate bill going further in that regard.
The good news: The FDA approved 18 new drugs during the first 8 months of this year. The not-so-good news: Last year, during the same time frame, the agency blessed 22 new drugs.
When the FDA published draft guidance on electronic source data in clinical trials back in January 2012, it sparked a widespread debate, some of which was critical of the proposals. Now, after a reworked draft was received more favorably by the industry, the administration has published its final guidance on the topic.