New FDA Rule Regarding Medical Device Data Systems Takes Effect
On April 18 an FDA rule governing the use of medical device data systems went into effect, implementing guidelines for IT companies that develop medical devices A new U.S. Food and Drug Administration rule went into effect April 18 that regulates how hardware manufacturers can introduce new mobile medical devices for use by health care […]
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FDA knew of problems at plant that made tainted alcohol wipes
The federal Food and Drug Administration is asking a Wisconsin firm tied to infections and death blamed on contaminated medical wipes to voluntarily stop making and distributing its drug products. May 11 Top Selling Webinar – FDA Compliance Ace John Avellanet Presents – FDA Expectations of Senior Management Save 50% Now with Offer Code 1012199 […]
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Anulex Technologies Endures Lay Offs After Warning Letter
Following a February warning letter from the U.S. Food and Drug Administration, Anulex Technologies has had to adjust by having a round of layoffs. President and General Manager Tim Miller declined to say how many people were let go but acknowledged that such letters were “extremely disruptive to business. †May 19 – Webinar – […]
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Regeneron eye drug gets priority FDA review
Regeneron Pharmaceuticals Inc. said Monday the Food and Drug Administration gave the company’s experimental treatment for an eye condition that can lead to blindness priority review status. The drug, called VEGF Trap-Eye, is aimed at treating wet age-related macular degeneration, which results in vision loss as new blood vessels grow in the eye and leak […]
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FDA Rejects New Cystic Fibrosis Drug
FDA has turned down Eli Lilly’s new drug application for liprotamase (Sollpura), a pancreatic enzyme product for cystic fibrosis and other diseases that cause pancreatic insufficiency, according to a press release from the company. The FDA told Eli Lilly that it needs to conduct an additional clinical trial prior to re-submission. May 11 Top Selling […]
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FDA Warns Doctors On Teva’s Generic Prevacid SoluTabs
The U.S. Food and Drug Administration is warning that a dissolvable generic heartburn drug made by Teva Pharmaceutical Industries Ltd. (TEVA, TEVA.TV) may clump and cause problems for patients using an oral syringe or feeding tube. The drug is a generic form of Prevacid SoluTabs, sold by the Japanese drug maker Takeda Pharmaceutical Co. Ltd. […]
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3 Pharmaceutical Industry CGMP Compliance Trends – April 18, 2011
3 Trends for April 18, 2011, from Pharmpro.com: 1. There is an emboldened FDA intent on measuring up under a keenly interested Congress. · There are sixteen (16) major pharma consent decrees dating from 1989 to 2010. What do they all have in common? No, it’s not bodies in the street. It’s GMP violations. Of […]
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J&J issues another recall, for epilepsy pills
Johnson & Johnson issued yet another recall Thursday, this one for about 57,000 bottles of a widely used epilepsy pill, because of complaints about a chemical odor. The health care giant said it is recalling two lots of 100-milligram tablets of Topamax, sold between Oct. 19 and Dec. 28, 2010. The lot numbers are OKG110 […]
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FDA finds more blood cancer with TNF blocker drugs
U.S. health regulators have received more reports of rare blood cancer in young patients taking a class of anti-inflammatory drugs used to treat digestive disorders. May 11 Top Selling Webinar – FDA Expectations of Senior Management Save 50% Now with Offer Code 1012199 The drugs, called tumor necrosis factor (TNF) blockers, are used to treat […]
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Philips Gets FDA Warning Letter Involving Defibrillators
Royal Philips Electronics NV (PHIA.AE) has received a U.S. Food and Drug Administration warning letter citing inadequate responses to issues with the company’s emergency defibrillators, including problems linked to deaths. The letter to Philips said the FDA found multiple violations during an inspection at the company’s Seattle facility last year. The letter also addressed issues […]
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