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House Overwhelmingly Passes MDUFA, Reconciliation With Senate Bill Is Next

June 1, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

The 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 | Comments

Product 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 | Comments

Device 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.

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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 | Comments

Amendment 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 | Comments

The 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 | Comments

Undeclared active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.

UDI Rule Could See Light of Day Soon, OMB Sign-Off Expected, FDAer Says

May 25, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

The Office of Management and Budget (OMB) could release the FDA’s proposed rule on a unique device identification (UDI) system “any day now,” an agency official says, ending a nearly year-long delay in finalizing the much-anticipated safety mechanism.

Final Senate MDUFA Package Omits Device Tax Repeal

May 25, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

The Senate voted 96-1 on Thursday to approve an omnibus FDA user fee bill, but earlier in the week rejected including an industry-backed amendment to repeal the upcoming medical device excise tax.

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Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software: Class I Recall - Potential Dosing Errors

May 25, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Problems associated with mix-ups related to salt-based or ion-based ordering of electrolytes.

FDA Safety Communication: Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis

May 25, 2012 6:31 am | by U.S. Food & Drug Administration | News | Comments

The FDA received a complaint describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate...

Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors

May 25, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

Risk of elevated bicarbonate levels in patients undergoing hemodialysis, which can contribute to metabolic alkalosis, a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.

Franck’s Compounding Pharmacy Sterile Preparations: Reports of Fungal Endophthalmitis, Expanded Recall

May 24, 2012 6:31 pm | by U.S. Food & Drug Administration | News | Comments

Recall of all products sold by Franck's since November 2011 due to the possibility of lack of sterility.

Hospira Carpuject Pre-filled Cartridges - Drug Alert: Products May Contain More Than the Intended Fill Volume

May 23, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

Healthcare professionals should visually inspect and confirm that the cartridge contains the labeled fill volume before dispensing and again before administering to patients.

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West Coast Nutritionals Dietary Supplement Products: Recall - Undeclared Drug Ingredient

May 21, 2012 7:31 am | by U.S. Food & Drug Administration | News | Comments

Products marketed as dietary supplements contains drug ingredient Tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

Public Meeting - Clinical Study Design and Performance of Hospital Glucose Sensors, June 25, 2012

May 21, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

FDA is seeking input from the clinical community, academia, Government, industry, clinical laboratories, and other stakeholders regarding clinical validation studies and performance criteria for innovative hospital glucose sensors...

Senate Vote on Revised User Fee Package Planned for This Week

May 18, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

The Senate plans to debate and vote on an omnibus FDA user fee bill this week, after lawmakers substituted a new bill for the prior reauthorization package and began discussing it on Thursday.

FDA Increasing Role in Quality Promotion for Devicemakers, CDRH Official Says

May 18, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

CDRH officials plan a series of public forums in 2012 to gather data to develop an implementation plan for the center’s Case for Quality Initiative – which aims to create an ongoing culture of quality at medical device manufacturers.

Requesting Speakers from CDRH

May 18, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

The following explains the process for requesting speakers from the Center for Devices and Radiological Health (CDRH) to participate in meetings, conferences, and workshops which are being sponsored by outside organizations...

Zithromax (azithromycin): FDA Statement on risk of cardiovascular death

May 17, 2012 12:31 pm | by U.S. Food & Drug Administration | News | Comments

A retrospective cohort study reports small increase in risk of cardiovascular deaths and risk of all cause deaths associated with 5 day course of antibiotic drug

Upcoming Webinar on Hearing Aids: The Basic Information You Need to Know (5/23/12)

May 15, 2012 9:30 am | by U.S. Food & Drug Administration | News | Comments

Learn more Wednesday, May 23, 2012 at 2:00 p.m. ET, when FDA's Center for Devices and Radiological Health (CDRH) will host a 30-minute Webinar to discuss basic information on Hearing Aids.

Impending IEC 60601 Leaves Medical Companies Struggling with Rules on Sustainable Design

May 15, 2012 5:48 am | News | Comments

The issue of ‘sustainability’ is becoming increasingly important for the medical industry since the implementation of the ‘International standard for environmentally conscious design of electronic medical equipment’ (IEC 60601-1-9) introduced in 2007.

Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume

May 14, 2012 9:30 am | by U.S. Food & Drug Administration | News | Comments

An overdose of Hydromorphone may result in life-threatening consequences, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.

Industry: IRS Needs to Better Define & #8216;Taxable Use & #8217; in Excise Tax Rule

May 11, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Internal Revenue Service guidelines on the 2.3 percent medical device tax should make clear that manufacturers won’t have to pay taxes on products from which they derived no direct benefit, such as demonstration products and replacement parts provided free of charge, AdvaMed said in...

MDUFA Moves to House Floor, Decision Summaries for Some 510(k)s Likely

May 11, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

An omnibus FDA user fee bill passed last week by the House Energy and Commerce Committee includes a variety of measures aimed at reforming the medical device regulatory process, including a provision requiring the FDA to withdraw its controversial guidance on when manufacturers should...

FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients

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

The FDA is alerting people with MS to the risks of serious injuries and death associated with procedures to treat chronic cerebrospinal venous insufficiency (CCSVI). Furthermore, the benefits of these experimental procedures have not been proven...

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