FDA’s CDER Has Ambitious ‘Front-Burner’ PrioritiesThey may need a bigger burner
Thu, 01/22/2015 - 11:13
The folks at the Center for Drug Evaluation and Research (CDER) released their sometimes optimistic, but always enlightening guidance wish list and overall priorities for 2015. Let’s take a look.
CDER director Janet Woodcock recently said these… Got Safe Beef?A new report suggests that the United States does not
Thu, 01/15/2015 - 15:15
The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Basically, anywhere but the United States of America.
Almost across the board, the United States ranks at the bottom (“… FDA’s Local Offices Flex Regulatory MuscleThe agency is holding medical device manufacturers accountable for eMDRs and CAPAs
Wed, 12/17/2014 - 16:26
A
s expected, the FDA is shifting more of its regulatory focus toward medical device reporting (MDR). In an Oct. 1, 2014, letter, the agency’s Baltimore district office hit Baltimore-based Electronic Development Labs for not having a MDR procedure… Medical Device Approval Still Lags, but the FDA Is TryingMaybe we should give the FDA a cheer instead of a kick in the rear
Tue, 11/18/2014 - 11:46
After years of decline, medical device approvals by the FDA have finally begun to hit the gas pedal, according to an interesting report from the California Healthcare Institute (CHI) and Boston Consulting Group (BCG).
In hindsight, it appears the… FDA Warning Letter Emphasis CAPA, CAPA, and more CAPA!
Thu, 11/06/2014 - 14:23
After a flurry of activity, it’s been relatively quiet lately on the FDA warning-letter front, though three device makers did get some bad news in recent weeks.
FDA’s Philadelphia office hit Pittsburgh-based Zoll Manufacturing Corporation, a maker… Medical Device Cybersecurity Risks The wrong kind of Halloween fright
Thu, 10/09/2014 - 16:37
Well, boys and girls, Halloween is approaching. Although it’s fun to don a Dracula (or Miley Cyrus) costume and get some yucks faux-scaring folks, the FDA is acting like a responsible parent by setting up a medical-device cybersecurity public… FDA Guidance Advises Device Makers to Think About Home UseConsider the human factor
Thu, 08/28/2014 - 12:37
Medical device manufacturers would be well-advised to address any risk with potential home-use products during their design phase, according to an August 2014 guidance from the FDA.
As the agency notes, “Failure to adequately consider potentially… FDA Lets MDDS Off the Regulatory HookAdministration cites low risk to patient safety
Tue, 07/22/2014 - 15:44
The U.S. Food and Drug Administration (FDA) won’t enforce compliance with regulatory controls that apply to medical device data systems (MDDS) and medical image communications devices, recognizing the “low risk” they pose to patient safety and the… Charles Darwin, Social Media, and the FDA’s New GuidanceThe FDA’s advice on handling criticism seems a bit obvious
Tue, 07/01/2014 - 10:23
If someone out in there in the wild wonderful world of the web takes a potshot at your drug or device, the first thing to do is take a deep breath and think. Any crisis communications executive worth her salt will tell you it’s often best to let… Medical Device Industry Endures Tough 20132014 prospects aren’t much better
Wed, 03/26/2014 - 16:35
It’s March 2014, but you could forgive medical device company leaders if they’re still smarting a bit from a generally tough 2013. Several new studies indicate a low level of mergers and financing occurred last year, which could slow product…
