This news is not surprising to anyone who pays attention to medical device recalls.
There has been a substantial jump in medical device recalls – up 97 percent over the last decade! This news comes from the division...more
The drug is on the market, so it must be safe, right? Although this assumption is entirely reasonable, it is not always true. The FDA approval and recall processes can allow harmful pharmaceuticals to remain on the market...more
In 2012, the Food and Drug Administration recalled Naturalyte and GranuFlo, which are manufactured by Frensenius Medical Care. Naturalyte and GranuFlo are used in the treatment of acute and chronic renal failure during...more
The procedure to implant a cardiac stent, which keeps blocked arteries open, includes inserting guidewires to move the device into place. Federal health officials have issued a warning about a defect in some Medtronic...more
Pharmacy compounding has been a very hot topic over the last 12 months. Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration (FDA) or action by a state board of...more
In March 2012, the manufacturer of NaturaLyte Liquid and NaturaLyte Granuflo Acid Concentrates issued a Class 1 recall of the products, which are used in hemodialysis to treat patients with acute and chronic renal failure. ...more
In 2011, the U.S. Food and Drug Administration began issuing warnings that birth control pills containing drospirenone — including brand names Yaz, Yasmin, Beyaz, Safyral and their generics Gianvi, Loryna, Ocella, Syeda and...more
Recall notification suggests the agency is ready and willing to use its new, enhanced enforcement authority.
On February 13, the U.S. Food and Drug Administration (FDA) began its first enforcement action under the...more
News reports are filled with frequent recalls of harmful and dangerous drugs. Many times, companies voluntarily issue a recall after receiving consumer complaints. However, in other situations the Federal Drug Administration...more
On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements. With the...more
On February 22, 2013, the Food and Drug Administration (“FDA”) issued draft guidance explaining when a change to a medical device constitutes a medical device recall as opposed to a “product enhancement.” This draft guidance...more
On January 8, 2013, a Minnesota federal district court granted summary judgment in favor of a policyholder who sought coverage from its commercial general liability insurer for contract damages stemming from the recall of...more
In the flurry of legislation passed by the 111th Congress in its final days, the Food Safety and Modernization Act (FSMA) cleared the Senate by unanimous voice vote on December 20, passed the House 215-144 the following day,...more
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