Senate joins House to pass sweeping new health bill
The U.S. Senate voted overwhelmingly on Wednesday to support sweeping legislation that will reshape the way the Food and Drug Administration approves new medicines.
Zimmer Holdings Inc said it received a warning letter from the U.S. Food and Drug Administration citing problems with manufacturing and testing processes for artificial hip devices made at the company's Ponce, Puerto Rico, plant.
The warning letter, dated September 19, does not restrict production or shipment of the hip devices, called Trilogy Acetabular Systems, or require withdrawal of any products from the market, Zimmer said in a regulatory filing.
The FDA said Zimmer failed to implement a testing mechanism to demonstrate the products met certain design specifications and had not validated the effects of manufacturing operations on products that incorporate metallic spikes.
The warning follows a June inspection of the company's Ponce plant. Zimmer said it temporarily suspended release of the affected products and has since completed the validation process for Trilogy products that do not incorporate metallic spikes.
The company expects to complete validation of Trilogy spiked products within the next few weeks.
(Reporting By Susan Kelly in Chicago; Editing by Carol Bishopric and Tim Dobbyn)
CLEVELAND Ohio lawmakers approved a bill that bans abortion once a fetal heartbeat can be detected, as early as six weeks after conception, clearing the way for one of the most stringent abortion restrictions in the United States if it becomes law.
Johnson & Johnson will challenge the fairness of a trial that produced a verdict of $1 billion in damages against the company last week over allegations of design flaws in its Pinnacle hip implant.