Stakeholder Meeting on MDUFA III Reauthorization September 6, 2011, 1:30 – 3:30 PM HHS Humphrey Building, Washington, DC Room 325A Purpose To provide a status update of the ongoing MDUFA III negotiations. Participants FDA Malcolm Bertoni Office of the Commissioner (OC) Ashley Boam Center for Devices and Radiological Health (CDRH) Nathan Brown Office of Chief…
Minutes From Negotiation Meeting on MDUFA III Reauthorization, August 31, 2011
FDA – Industry MDUFA III Reauthorization Meeting August 31, 2011, 10:00 am – 12:30 pm FDA White Oak Building 1, Silver Spring, MD Room 4101-4105 Purpose To discuss MDUFA III reauthorization. Participants FDA Malcolm Bertoni Office of the Commissioner (OC) Ashley Boam Center for Devices and Radiological Health (CDRH) Kate Cook Center for Biologics Evaluation…
FDA Safety Communication: Preventing Surgical Fires
Date Issued: Oct. 13, 2011 Audience: All health care professionals (surgeons, surgical technicians, anesthesiologists, CRNAs, nurses, etc.) involved in surgical procedures. Health care facility executives and staff responsible for patient safety and risk management. Products: Medical products used in surgical procedures, including medical gases, alcohol-based skin preparation agents, electrosurgical units (ESUs), lasers, and fiber optic…
Decorative Contact Lenses
Pseudomonas eye infection. Image courtesy of Thomas Steinemann, MD and MetroHealth Medical Center You may want to look like your favorite movie star or singer or have the perfect look for Halloween, but choosing to change the look of your eyes with contact lenses could cause a lot of damage to your eyesight. Decorative contact…
FDA Drug Safety Communication: Sprycel (dasatinib) and risk of pulmonary arterial hypertension
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [10-11-2011] The U.S. Food and Drug Administration (FDA) is warning the public that the leukemia drug Sprycel (dasatinib) may increase the risk of a rare, but serious condition in which there is abnormally high blood pressure in the arteries of the lungs…
Sprycel (dasatinib): Drug Safety Communication
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FDA-CMS Parallel Review
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Uprizing 2.0: Recall
[Posted 10/06/2011] AUDIENCE: Consumer ISSUE: FDA notified the manufacturer that lab analyses found that the product, sold as a testosterone booster, contains superdrol, a synthetic steroid, making it an unapproved new drug. Acute liver injury is known to be a possible harmful effect of using products containing synthetic anabolic steroids. In addition, use of synthetic…
Minutes From Negotiation Meeting on MDUFA III Reauthorization, August 24, 2011
FDA – Industry MDUFA III Reauthorization Meeting August 24, 2011, 1:00 – 5:00 pm FDA Switzer Building, Washington, DC Room 1007 Purpose To discuss MDUFA III reauthorization. Participants Meeting Start Time: 1:15 pm The Agency provided a response and counter-proposal to Industry’s* July 26, 2011 proposal that the Agency viewed as being responsive to Industry’s…
Phase-Out of Albuterol CFC Metered-Dose Inhalers
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