Expert: Cool Down on Hot CAPADon’t make mountains (of work) out of minor mistakes
Wed, 05/08/2013 - 09:45
It’s no secret that Food and Drug Administration (FDA) inspectors hone in on a medical device company’s corrective and preventive action (CAPA) program during an inspection. But a leading CAPA consultant says many companies may have overreacted and… The FDA Is Taking Its Act Abroad And isn’t liking some of what it found
Thu, 04/18/2013 - 10:34
The latest batch of Food and Drug Administration (FDA) inspection letters noting objectionable conditions, aka 483s, has a decidedly international flair: Italy, Japan, and Canada had the pleasure of hosting FDA inspectors in recent months. Three… Grow the Carrot, Chop the TreeMedical-device product failure is a sequoia-sized problem in need of a quality management chain saw
Wed, 03/27/2013 - 09:57
The giant sequoia trees on the Pacific Coast are breathtaking. Majestic and seemingly indestructible, they stand tall as a reminder that slow and steady sometimes does win the race. But what’s great in a forest isn’t always so great elsewhere.
Let… Raise a Glass to a Dumb Medical Device Tax Brewed in D.C.Consumers, not companies, will foot the medical device excise tax
Mon, 03/11/2013 - 13:07
A prominent politician goes before his constituents during a tough reelection campaign. He’s introduced by the local mayor, and strides to the stage, waving and smiling to enthusiastic applause.
“It’s great to be here with you tonight. I love this… Study: FDA Enforcement Growing for Medical Device CompaniesCDRH inspections account for 10–12 percent of all FDA inspections
Thu, 02/14/2013 - 11:04
Turns out that some paranoid people have a reason to, well, be paranoid. Researchers from the London Business School issued a report last year finding that many people at work who thought they were being talked about were probably right.
Maybe… White House Science Council Pushes for Faster Drug ApprovalsRecommends doubling output of critical new medicines during the next 15 years
Tue, 10/16/2012 - 16:49
There are two things right now that get relatively bipartisan support in Washington, D.C. The first is that a major league baseball team in D.C. won a pennant for the first time since we stopped huddling around our radios for entertainment. [Editor’… What the Heck’s Going On at the FDA?FDA caught spying on its scientists
Mon, 07/23/2012 - 13:07
The Cold War may be over, but apparently spying is still a growth industry. The latest spy-craft news comes from the seemingly staid Food and Drug Administration (FDA), which appears to have more George Smiley and John le Carré types than we’d ever… FDA and EU Spar on Medical Device RegulationJust paying attention, says FDA; that’s hypervigilence, counters EU
Tue, 05/01/2012 - 11:43
Sure, the Italians have better food, the English richer royal culture and accents, and French women don’t get fat, but we in America regulate medical devices better, don’t we? Not so fast, says the European Union.
They apparently aren’t happy that… Medical Device CEO Laments ‘Anti-Industry’ FDA CultureIs the agency stifling medical innovation?
Wed, 04/18/2012 - 11:16
While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the Food and Drug Administration’s (FDA) attempt to “force its own agenda” over dissenting science or how its own advisory… Lawmakers’ Silly Season No Laughing Matter for Device IndustryMedical device firms are always one recall away from increased scrutiny
Wed, 03/28/2012 - 10:29
Predicting things on Capitol Hill is never easy, especially as the election campaign “silly season” enters the picture, but it’s beginning to look like medical device companies should expect heavier regulation in 2012, and that will only increase if…
