Regulatory
Cefepime:Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment
June 26, 2012 11:30 am | by U.S. Food & Drug Administration | News | CommentsHealth care professionals should adjust the dosage of cefepime in patients with creatinine clearance less than or equal to 60 mL/min.
OSC Surveillance Guidance Proves FDA Wrongdoing: Lawyers for Whistleblowers
June 22, 2012 2:31 pm | by U.S. Food & Drug Administration | News | CommentsA new memorandum issued by the U.S. Office of Special Counsel (OSC) instructing federal agencies to ensure their electronic surveillance policies and practices do not deter whistleblowing “confirms” the FDA broke the law when it allegedly monitored the personal emails of...
MDUFA Passes Final House Vote With Few Changes to Device Provisions
June 22, 2012 2:31 pm | by U.S. Food & Drug Administration | News | CommentsThe House Wednesday overwhelmingly approved reauthorizing the Medical Device User Fee Act (MDUFA), sending it on to the Senate with a voice vote.
Nidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators: Class I Recall - Risk of Fire, Loss of Supplemental Oxygen
June 21, 2012 12:30 pm | by U.S. Food & Drug Administration | News | CommentsA capacitor failure may result in a fire hazard and loss of supplemental oxygen, which can lead to serious adverse health consequences, including death.
Class I Medical Device Recall: Nidek Medical Products, Inc., Mark 5 Nuvo, Nuvo 8 and Nuvo Lite Oxygen Concentrators
June 21, 2012 11:30 am | by U.S. Food & Drug Administration | News | CommentsReason for Recall: Capacitor failure may result in a fire hazard and loss of supplemental oxygen. These products may cause serious adverse health consequences, including death.
Summary Information for: Access & #xae; Hybritech p2PSA on the Access Immunoassay Systems
June 20, 2012 11:30 am | by U.S. Food & Drug Administration | News | CommentsLabeling, Approval Order, and Summary of Safety and Effectiveness for Access® Hybritech p2PSA on the Access Immunoassay Systems (P090026).
Consumer Information on: Access & #xae; Hybritech p2PSA on the Access Immunoassay Systems - P090026
June 20, 2012 11:30 am | by U.S. Food & Drug Administration | News | CommentsThe Access® Hybritech p2PSA on the Access Immunoassay Systems is an automated laboratory test that measures how much [-2]proPSA a man has in his blood.
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis
June 20, 2012 5:30 am | by U.S. Food & Drug Administration | News | CommentsThis draft guidance document was developed as a special control guidance to support the reclassification of the Implanted Blood Access Devices for Hemodialysis into class II (special controls). The device, as proposed, is intended to provide access to a..
Consumer Information on: PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) - P110010/S001
June 18, 2012 10:30 am | by U.S. Food & Drug Administration | News | CommentsThe PROMUS Element stent is a metal stent with the drug everolimus contained in a thin coating on the stent?s surface. The PROMUS Element stent is mounted on a folded balloon attached to a catheter delivery system for placement into a coronary artery...
Summary Information for: PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)
June 18, 2012 10:30 am | by U.S. Food & Drug Administration | News | CommentsLabeling, Approval Order, and Summary of Safety and Effectiveness for PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P110010S001).
Add Cyber Security Evaluation to Device Design Process: Expert
June 15, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsMedical devicemakers that don’t audit their products for computer security could be putting patients at risk, a cyber security expert says.
Grassley: FDA Unresponsive to Requests for & #8216;FDA Nine & #8217; Records
June 15, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsCongressional lawmakers say the FDA is holding up their investigation into reports the agency monitored the personal emails of employees who voiced product safety concerns to Congress, noting that almost five months have gone by without an agency response to a request for key documents.
PMA Final Decisions for April 2012
June 15, 2012 9:30 am | by U.S. Food & Drug Administration | News | CommentsThese are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for April 2012.
Ethicon Asks FDA for 120 Days to Pull Vaginal Mesh From Market
June 8, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsJohnson & Johnson’s (J&J) Ethicon unit will halt sales of some vaginal mesh products implicated in a class action lawsuit, but says it needs time to conduct the withdrawal properly.
Device Tax Repeal Passes House, Industry Takes Battle to Senate
June 8, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsOpponents of the medical device excise tax, mandated in the 2010 Affordable Care Act, are one step closer to repealing the contentious measure, after the House voted 270-146 to pass H.R. 436, the Protect Medical Innovation Act.
Digestive 3 in 1 Health Liquid Dietary Supplement: Recall - Potential for Contamination With Salmonella
June 7, 2012 10:30 am | by U.S. Food & Drug Administration | News | CommentsRisk of serious and sometimes fatal infections, especially in young children, frail or elderly people, and others with weakened immune systems.
Wrinkle Fillers Approved by the Center for Devices and Radiological Health
June 7, 2012 7:30 am | by U.S. Food & Drug Administration | News | CommentsFDA approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of the wrinkle fillers when injected into specified areas of facial tissue. More information about the data FDA reviewed to...
Introvale (levonorgestrel and ethinyl estradiol) Tablets: Recall - Packaging Flaw
June 6, 2012 1:30 pm | by U.S. Food & Drug Administration | News | CommentsRisk of an unintended pregnancy for a patient taking the wrong tablet over several days.
Device Tax Repeal Measure Passes Committee, Sent To House Floor
June 1, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsThe House Ways & Means Committee Thursday approved legislation, H.R. 436, to repeal the medical device excise tax — delighting industry.
House Overwhelmingly Passes MDUFA, Reconciliation With Senate Bill Is Next
June 1, 2012 2:30 pm | by U.S. Food & Drug Administration | News | CommentsThe House voted 387-5 Wednesday evening to pass an omnibus FDA user fee bill, giving lawmakers most of June to iron out differences between that measure and one the Senate passed May 24.
Reumofan Plus: Recall - Undeclared Drug Ingredient
June 1, 2012 10:30 am | by U.S. Food & Drug Administration | News | CommentsProduct contains potentially harmful active pharmaceutical ingredients that may interact with other medications and result in serious adverse events.
MOOG Medical Devices Group, Curlin Infusion Administration Sets: Class I Recall - Potential for Reverse Flow of Fluid
June 1, 2012 5:31 am | by U.S. Food & Drug Administration | News | CommentsDevice malfunction may cause blood loss, an under-delivery of prescribed medicines or fluids, or a potential delay in therapy, leading to serious adverse health consequences, including death.
Amendment of Meeting Notice; June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
May 31, 2012 2:30 am | by U.S. Food & Drug Administration | News | CommentsAmendment of Meeting Notice; June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
Teva’s Adderall 30 mg Tablets: Counterfeit Product - Contains Wrong Active Ingredients
May 30, 2012 4:30 am | by U.S. Food & Drug Administration | News | CommentsThe counterfeit versions of Adderall should be considered as unsafe, ineffective and potentially harmful.
V Maxx RX: Recall - Undeclared Drug Ingredient
May 29, 2012 4:30 am | by U.S. Food & Drug Administration | News | CommentsUndeclared active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.
