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Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill Volume

April 18, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

Consequences of opioid pain medication overdose can be life-threatening, including respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

Consumer Information on: ARCHITECT HBsAg - P110029

April 17, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

These reagents are used with the Abbott ARCHITECT Instrument System to identify certain virus proteins associated with hepatitis B virus (HBV). If these virus proteins are present, then the patient is likely to be infected with HBV.

Summary Information for: ARCHITECT HBsAg

April 17, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for ARCHITECT HBsAg (P110029).

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Harry and David Issues Allergy Alert on Undeclared Peanuts in Harry & David Premium Kansas City Style Barbeque Almonds

April 13, 2012 8:31 pm | by U.S. Food & Drug Administration | News | Comments

Harry and David, is voluntarily recalling approximately 205 2 oz. bags labeled Harry & David Premium Kansas City Style Barbeque almonds, because the bags may contain peanuts. Peanuts are not declared as ingredients, but the label includes the statement "May contain trace amounts of...

Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product

April 13, 2012 8:30 pm | by U.S. Food & Drug Administration | News | Comments

• Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a...

Breast Cancer Ultrasound Device Gets Favorable Panel Recommendation

April 13, 2012 2:32 pm | by U.S. Food & Drug Administration | News | Comments

An FDA advisory panel unanimously recommended approval of a new tool for detecting breast cancer, but advised against Class I status for a preamendment device used for the same purpose.

U.S. Should Bring Developing Nations on Board to Tackle Import Problems: Report

April 13, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA and other agencies must provide expertise, training and tools to developing nations to improve their medical technology monitoring practices and prevent dangerous medical products from entering the U.S., according to an Institute of Medicine (IOM) report. The recommendation is one...

PMA Final Decisions for February 2012

April 13, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for February 2012.

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Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots

April 10, 2012 10:31 am | by U.S. Food & Drug Administration | News | Comments

Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

CDRH Learn (New Module - Factors to Consider When Making Benefit-Risk Determinations in Medical Device PMA and De Novo Classifications)

April 10, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

This guidance document was developed to identify and clarify the factors FDA considers when making benefit-risk assessments in PMA applications, and de novo classification petitions for medical devices.

CDRH Misses MedSun Goals, Cites Success in MDR Reviews, Other Areas

April 6, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Recent agency data show CDRH making slow but steady progress toward several strategic goals — but missing the mark on the Medical Product Safety Network (MedSun) initiative.

Senators Set June Deadline for Sunshine Implementation

April 6, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

The senators who co-authored the Physician Payments Sunshine Act are trying once more to exercise their legislative oversight — this time setting a June deadline for overdue implementation of the rules.

Guidance for Industry and Food and Drug Administration Staff - User Fees for 513(g) Requests for Information

April 6, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA), also termed the Medical Device User Fee Amendments of 2007, P.L. 110-85, extends FDA?s authority to collect medical device user fees by establishing a fee for ?a request for...

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Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmet...

April 6, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

The purpose of this guidance is to establish procedures for submitting, reviewing and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug,

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (June 21, 2012)

April 4, 2012 9:31 pm | by U.S. Food & Drug Administration | News | Comments

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Class 1 Recall- Outflow Graft May Kink or Deform

April 4, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

May result in reduction of blood flow from the pump, pump/graft thrombosis, or perforation of the outflow graft.

Class I Medical Device Recall: Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS)

April 4, 2012 9:31 am | by U.S. Food & Drug Administration | News | Comments

Detachment of the bend relief from its intended position around the proximal outflow graft may allow the graft to kink or deform, resulting in reduction of blood flow from the HeartMate II LVAS pump, pump/graft thrombosis, or perforation of the outflow...

Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient

April 3, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The counterfeit product may have resulted in patients not receiving needed therapy.

Wingspan Stent & #8217;s Benefits Don & #8217;t Justify Risks, Panel Concludes

March 30, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Stryker’s Wingspan stent could be yanked from the market if the FDA heeds March 23 recommendations of its Neurological Devices Panel.

Shuren Predicts CDRH & #8216;Death Spiral & #8217; Absent Timely MDUFA Passage

March 30, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

CDRH would move into a “death spiral” if Medical Device User Fee Act (MDUFA) legislation is not reauthorized this summer, director Jeffrey Shuren warned at a Senate Health, Education, Labor & Pensions (HELP) committee hearing Thursday.

Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms

March 28, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

Revised drug label clarifying dosing and warning recommendations.

Guidance: Class II Special Controls Guidance Document: Full Field Digital Mammography System

March 27, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

FDA has developed this guidance as the special control to support classification of full-field digital...

New FDA guidance on considerations used in device approval, de novo decisions

March 27, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments

FDA has published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits...

Pilot Would Reduce Audit Frequency Using Harmonized Regulations

March 23, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Starting June 5, devicemakers audited according to internationally harmonized regulatory standards could be spared some annual FDA inspections, under a pilot program described in a final guidance.

U.S. Supreme Court Prometheus Ruling May Limit Future Research

March 23, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Last week’s U.S. Supreme Court decision on the patent eligibility of a diagnostic could have ramifications for in vitro diagnostic (IVD) devicemakers, limiting investment in novel tests because of uncertainty about what is and is not patentable, a U.S. patent attorney tells D&DL.

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