When the U.S. Food and Drug Administration cleared for the first time a surgical device that can be assembled and disassembled inside a patient’s body, not a lot of people noticed.That’s probably because the manufacturer, a Cincinnati-based surgical products division of Johnson & Johnson called Ethicon Endo-Surgery, hasn’t yet launched the product — and maybe [...]

Healthcare venture capitalists are no fans of the U.S. Food and Drug Administration and the regulatory challenges the agency poses for medical startups and device companies.They blame many of the problems besetting healthcare investing squarely on the agency as delays caused by reviewers push investor pay day further out.But at the MedTechInvesting Conference in Minneapolis [...]

A drug to treat a genetic disease that leads to the growth of noncancerous tumors in the kidneys and brain has received accelerated approvalfrom the U.S. Food and Drug Administration.Novartis’ (NYSE:NVS) drug called everolimus and marketed as Afinitor treats the kidney tumors called renal angiomyolipomas and brain tumors known as SEGAs that are produced by [...]

A Swiss plasma product manufacturer’s U.S. division, Octapharma USA, has received a warning letter from the U.S. Food and Drug Administration over what was described as “false and misleading” advertisements in a journal and product catalog.The U.S. regulator said in the April 10 letter that an ad for its octagam immune globulin intravenous 5% published [...]

The U.S. Food and Drug Administration has cited several violations by an orthopedic medical devices startup that produces implants and screws used for orthopedic surgery on hands, wrists, feet and ankles in a warning letter to the company.Among the infractions by Extremity Medical cited in the warning letter dated Feb. 24 were two cases in [...]

Analyst Debbie Wang of Morningstar remembers that day in October 2009 when obesity treatment firm EnteroMedics (NASDAQ:ETRM) held a conference call to explain that its highly anticipated Maestro device had failed to meet a goal in a clinical trial.“Honestly, the CEO sounded like he was shell-shocked,” she recalled. “He sounded like he couldn’t believe it. [...]

The U.S. Food and Drug Administration is warning hospitals to stop using an ultrasound gel produced in the second half of 2011 because it has been linked to at least 16 bacterial infections. The health risk prompted the FDA to call in U.S. Marshals to seize the gel in a raid on the New Jersey [...]

Despite encouraging sales performance in the first quarter for recently approved oncology drugs, Johnson & Johnson (NYSE:JNJ) continues to be vexed by manufacturing problems. That, coupled with new questions over its incoming CEO, paint a mixed picture for how 2012 will shake out for the pharmaceutical and medical device giant.A consent decree from the U.S. [...]

Disruptive, fast prototyping, iterative, warp speed.These are not words people typically associate with the U.S. Food and Drug Administration’s medical device review process.But in a media briefing on Monday, those words were bandied about liberally and signaled that federal bureaucrats are attempting to embrace a culture of innovation in their effort to help companies commercialize novel, safe products more quickly than before.

For early stage drug and device companies, communication in the preclinical stage is much more about listening than putting out your own message.Nonetheless, these early communications establish the foundation for the company and will be key to achieving U.S. Food and Drug Administration approval down the road.For example, a strong early communications strategy can set [...]