Intuitive Surgical is facing legal pushback from shareholders who claim that the company underreported adverse events and concealed recalls from the FDA related to its robotic surgical device, MassDevice reported.
Pfizer's approval pathway for its meningococcal B vaccine just got shorter. On Thursday, the FDA designated the candidate, dubbed rLP2086, as a breakthrough therapy, which will speed its trip through the regulatory process--and put it in a head-to-head battle with Novartis' Bexsero.
The FDA has now signed off on Janssen's process of manufacturing bulk Doxil at an Ohio facility. It is part of an "alternative manufacturing process" in which the company hands off fill and finish of the drug to another manufacturer.
In India, state regulators assume oversight of a drug manufacturing facility about four years after a plant has been approved, a system some have criticized for being inconsistent and ineffective. But Indian state regulators have taken action against two Wockhardt plants that the U.S. FDA banned months ago from shipping products to the U.S.
"Medical device recalls nearly doubled in a decade," proclaims The Wall Street Journal 's headline--a bit of data the FDA is expected to release Friday that seems likely to travel far on social media. Critics are already making hay, questioning the rigor of pre-market vetting at the FDA.
In a major regulatory win, Cochlear--the world's largest maker of hearing aids--scored FDA approval for its next-generation hearing device to treat sensorineural hearing loss.
With FDA bans of products from some of India's largest drugmakers has come growing debate about the quality of drugs shipped to the U.S. Now sampling by the Drug Controller General of India since December 2012 has found that about 2.3% of products tested failed to meet standards.
Bacterin International, a maker of bone-graft materials and medical coatings, reported a slight increase in 2013 revenues of $33.1 million compared to $30 million the previous year, though net losses for the year jumped to $12.7 million from $7.7 million in 2012.
For years the FDA has been trying to level the playing field in terms of foreign versus domestic drug manufacturing plant inspections. It wasn't many years ago when U.S. facilities could expect a visit every 30 months while foreign plants would go 5 or more years between inspections. One way to achieve parity is to cut the number of U.S. inspections while doing more overseas, and that is what the FDA proposes to do.
The mobile medical app regulation saga continues: Congress sent the FDA a letter this week to inquire about the agency's regulation of the technology and to clarify a few talking points, MobiHealthNews reported.