February 11, 2010FDA Requests $4.03 Billion to Transform Food Safety System, Invest in Medical Product Safety, Regulatory Science FDA Requests $4.03 Billion to Transform Food Safety System, Invest in Medical Product Safety, Regulatory Science
The U.S. Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the President’s fiscal year 2011 budget – a 23 percent increase over the agency’s current $3.28 billion budget. The FY 2011 request, which covers the period of Oct.1, 2010, through Sept. 30, 2011, includes increases of $146 million in budget authority and $601 million in industry user fees. Source: www.fda.gov Edwards Lifesciences Aquarius Hemodialysis System: Recall Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm. Source: www.fda.gov Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension Risk information added to Warnings/Precautions section and data summary provided Source: www.fda.gov FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography. Source: www.fda.gov Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall Class I recall due to "coring" or dislodging of silicone cores or slivers from the ports into which they are inserted. Source: www.fda.gov Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored. Source: www.fda.gov FDA Issues Guidance to Help Streamline Medical Device Clinical Trials The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies. Source: www.fda.gov Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots [UPDATE 01/15/2010] Recall expanded from December 2009 due to reports of moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. Posted 12/28/2009 Source: www.fda.gov McNeil Consumer Healthcare Over-The-Counter Products: Recall December 2009 recall expanded to multiple products. Source: www.fda.gov # posted by Network @ 9:13 PM
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