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07/18/11 The U.S. Food and Drug Administration (FDA) just issued a notification to the medical imaging community and the public concerning the potential for inadvertent, increased radiation exposure in patients who underwent or will undergo cardiac positron emission tomography (PET) scans with rubidium (Rb)-82 chloride injection from CardioGen-82, a device manufactured by Bracco Diagnostics, Inc. The ...
07/18/11 A foodborne illness outbreak associated with raw milk from Tucker Adkins Dairy of York, South Carolina involves three confirmed and five probable cases of campylobacteriosis seen in North Carolina, the U.S. Food and Drug Administration (FDA) just announced. According to the FDA, raw milk is unpasteurized milk from hoofed mammals, such as cows, sheep, [...]
07/18/11 The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United States.
07/18/11 MONDAY, July 18 (HealthDay News) -- Influenza may be far from most Americans' thoughts as much of the nation wilts under oppressive heat, but the U.S. Food and Drug Administration said Monday that it's already preparing for the 2011-12 flu season.
07/18/11 MONDAY, July 18 (HealthDay News) -- The 2011-12 influenza vaccine, containing the three strains predicted most common in the upcoming season, has been approved by the U.S. Food and Drug Administration.
07/18/11 According to an announcement from the Food and Drug Administration (FDA) on Monday, it has approved the new flu vaccine for the season beginning this year. Each year the FDA works with other federal agencies and global health experts to design a vaccine to protect against the three viral strains most likely to cause the flu.
07/18/11 MedImmune has received confirmation from the U.S. Food & Drug Administration that the Agency has filed the Company's supplemental Biologics License Application for a quadrivalent version of FluMist?® .
07/18/11 GAITHERSBURG, Md., July 18, 2011 /PRNewswire/ -- MedImmune has received confirmation from the U.S. Food & Drug Administration (FDA) that the Agency has filed the Company's supplemental Biologics License Application (sBLA) for a quadrivalent (four-strain) version of FluMist?® (Influenza Vaccine Live, Intranasal).
07/14/11 Dairy cows sold for slaughter in New Mexico were found to have drug residues, according to the U.S. Food and Drug Administration (FDA).
07/14/11 BRIDGEWATER, NJ--(Marketwire - 07/14/11) - Aptalis Pharma, a global specialty pharmaceutical company focused on gastrointestinal diseases and cystic fibrosis (CF), today announced that the U.S. Food and Drug Administration (FDA) has approved a new strength of ZENPEP (pancrelipase) Delayed-Release Capsules. The new formulation will be offered in 25,000 units of lipase, the highest strength ...
07/14/11 Women who have vaginal surgery to fix a common gynecologic condition called pelvic organ prolapse may wind up with more problems than benefits if a plastic mesh is used, according to a safety communication issued yesterday by the Food and Drug Administration.
07/13/11 Agency says other options may expose women to less risk than transvaginal procedure SILVER SPRING, Md., July 13, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued an updated safety communication warning health care providers and patients that surgical placement of mesh through the vagina to repair pelvic organ prolapse may expose patients to greater risk than ...
07/12/11 On Monday, the U.S. Food and Drug Administration conditionally approved the study design for a Medtronic (NYSE:MDT) product that company officials believe represents a multibillion-dollar opportunity. The product is the Simplicity catheter-based system to treat hypertension, or high blood pressure, and it came to Medtronic through the acquisition of Mountain View, California-based Ardian. The ...
07/12/11 ACTON, MA--(Marketwire - 07/12/11) - MacPherson Medical, the developers of Stat-Mat, received U.S. Food and Drug Administration 510(k)clearance for its flagship product, Stat-Mat Minor. Available and shipping today, Stat-Mat Minor is designed to eliminate inefficient prep time in the operating room. Reducing instrument set-up from as much as 15 minutes to only 10 seconds, it affords the ...
07/11/11 TUESDAY, June 21 (HealthDay News) -- In a dramatic bid to get more Americans to quit smoking, the U.S. Food and Drug Administration on Tuesday released nine graphic warning labels that will appear on all packs of cigarettes by no later than September 2012.
07/11/11 SATURDAY, Jan. 29 (HealthDay News) -- An advisory panel to the U.S. Food and Drug Administration decided on Friday that electroconvulsive (also known as "electroshock") devices should be subject to the same tough testing as other medical devices entering the market.
07/11/11 THURSDAY, May 19 (HealthDay News) -- A new test to detect whether a toxoplasmosis infection has been acquired within the past four months has been approved by the U.S. Food and Drug Administration.
07/11/11 TUESDAY, Nov. 2 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) is not doing its job of properly monitoring the safety of medical devices, the authors of a new report charge.
07/11/11 Nearly 400,000 women receive breast implants each year, and many are picking silicone material. But in a recent report, the Food and Drug Administration warned that many women experience complications from silicone from a hardening of the skin around the implant to ruptures, pain and...
07/10/11 Is the U.S. Food and Drug Administration a bumbling bureaucracy that is "stifling American innovation, costing American jobs, and hurting American patients," as a House subcommittee member suggested Thursday?
07/09/11 The U.S. Food and Drug Administration has announced changes to the labels of over-the-counter sunscreen, changes that could help reduce confusing and misleading information for consumers by summer 201 |