Outlook for the medical device industry in 2013
Source The 2013 Medical Device Industry Survey was conducted in January 2013, with a total of 3,509 respondents. Only one response per person was allowed. Survey questions were emailed to an in-house list maintained by Emergo Group. A publicly available online link to the survey also solicited responses from industry via social media channels. Due […]
Read More »Category : News
Questionable Impotence Ads Gain FDA Attention
source Several years ago, the drugmakers that sell impotence pills convinced Congress that federal regulations were not required to ensure objectionable ads would not be seen by children. However, a new study charges that industry efforts to regulate direct-to-consumer advertising have been a “ruse†designed to deflect criticism and block Congress from intervening. From 2006 […]
Read More »Category : News
CDMO Sovereign takes it on the chin in FDA
The FDA has found issues with a plant operated by contract manufacturer Sovereign Pharmaceuticals, saying the plant is not only having problems with its GMP manufacturing but also is producing over-the-counter meds that don’t qualify for that category. The agency today posted a warning letter to the company for inspections that occurred more than a […]
Read More »Category : News
Search appears on FDA’s radar once again
The Food and Drug Administration (FDA) has taken a Florida nutritional supplements company to task for the way it uses search technology. The US regulator issued a warning letter to Medical Doctors Research (MDR) in January after the company was found to have failed to comply with manufacturing regulations. Following the FDA’s July-August inspection last […]
Read More »Category : News
Integra LifeSciences Gets FDA Warning Letter On Puerto Rico Facility
Integra LifeSciences Holdings Corp. ( IART) announced that on February 14, 2013, it received a warning letter from the United States Food and Drug Administration or FDA related to quality systems issues at its manufacturing facility located in Añasco, Puerto Rico. The letter resulted from an inspection conducted at that facility during October and November […]
Read More »Category : News
Teen shot at Bothell FDA lab released from custody
A teenage boy who was shot in the foot after he allegedly drove a car into a contract security guard at the Food and Drug Administration lab in Bothell on Feb. 8 is out of juvenile detention, according to Snohomish County prosecuting attorneys. He has not been charged with a crime in connection with the incident […]
Read More »Category : News
Novartis Dumps $78 Million Bonus to CEO
Source In a rare instance in which outrage over executive compensation sparked a change of heart, Novartis unexpectedly canceled a six-year payout worth up to $78 million that was to have been paid outgoing chairman Dan Vasella as part of a new non-compete agreement. The basic terms of the deal had been disclosed over the […]
Read More »Category : News
Average time to FDA clearance drops again, mobile medical apps still shorter
Perhaps more than any other metric, the time it takes to secure clearance is the one that gets the most attention for 510(k) devices. An updated analysis from medical device quality assurance and regulatory consultants, The Emergo Group, finds that the average time it took for a medical device to complete the 510(k) process was […]
Read More »Category : News
FDA raid company in Florida for illegal dietary supplements
The FDA and U.S. marshals have raided a company in Flordia called Globe All Wellness LLC and have seized supplies of the dietary supplement Meridia, a weight loss drug that was withdrawn from the market in 2010. The U.S. Food and Drug Administration (FDA) has stated that the illegal dietary supplements from the Florida based […]
Read More »Category : News
Congress Orders FDA to Reclassify Pain Killers – Now
Source One month after an FDA advisory panel voted 19-to-10 to place Vicodin and other prescription painkillers that contain hydrocodone under greater restrictions, a bipartisan group of members of Congress have written the FDA to demand the agency take “swift action†to follow the recommendation and produce a timeline for doing so. And in their […]
Read More »Category : News
