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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.

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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...

Pediatric X-ray Imaging

May 10, 2012 1:30 am | by U.S. Food & Drug Administration | News | Comments

Medical imaging has led to improvements in the diagnosis and treatment of numerous medical conditions in children and adults. There are many types - or modalities - of medical imaging procedures that are used on children, each of which uses different...

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Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

May 10, 2012 1:30 am | by U.S. Food & Drug Administration | News | Comments

Like all medical procedures, computed tomography (CT), fluoroscopy, and nuclear medicine imaging...

Public Workshop - Device Improvements for Pediatric X-ray Imaging, July 16, 2012

May 9, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

The main purpose of the workshop is to discuss the draft guidance Pediatric Information for X-ray Imaging Device Premarket Notifications. This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and...

Draft Guidance for Industry and Food and Drug Administration Staff - Pediatric Information for X-ray Imaging Device Premarket Notifications

May 9, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

This guidance document outlines the FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use in pediatric populations. The Agency intends for this guidance to minimize...

Innovation Pathway Advances May Be Expanded Throughout Agency

May 4, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

CINCINNATI — Regulatory advances made during the Innovation Pathway 2.0 project to develop new treatments for end-stage renal disease may quickly be rolled throughout CDRH, center Director Jeffrey Shuren said Wednesday at the FDA/Xavier University MedCon Conference here.

Devicemakers Could Gain from Obama & #8217;s Call for More Regulatory Harmonization

May 4, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA may need to better match its regulations with those of key trading partners, a move that could benefit the increasingly global device industry, thanks to a new executive order (EO), 13609, signed by President Barack Obama Tuesday.

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Certain Compounded Drugs from Franck's: FDA Issues Second Warning to Physicians(2)

May 4, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

[UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation.

Sound Interventions Completes 'First-In-Human' Feasibility Trial of Ultrasound-Based Renal Denervation System For Resistant Hypertension

May 4, 2012 6:04 am | News | Comments

Sound Interventions, Inc. today announced the successful completion of the company's First-In-Human clinical trial to treat resistant hypertension. The study was performed by Dr. Petr Neuzil and a team of cardiologists at Holmolka Hospital in Prague, Czech Republic.

Clinical trial via supercomputer could reduce expense of using patients

May 4, 2012 5:54 am | News | Comments

One of the biggest complaints about the U.S. regulatory system is that the clinical trials required to prove safety and efficacy are prohibitively expensive. But could technology help to justify that cost or reduce costly errors related to clinical trial design?

Mammography Facility Adverse Event and Action Report - May 2, 2012

May 3, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

As part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and...

Consumer Information on: Presillion plus CoCr Coronary Stent on RX System - P110004

May 1, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

The Presillion plus CoCr Coronary Stent on RX System is a metal stent that is mounted on a folded balloon attached to a catheter delivery system for placement into a blood vessel supplying blood to the heart (coronary artery). The stent is made of a...

Summary Information for: Presillion plus CoCr Coronary Stent on RX System

May 1, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Presillion plus CoCr Coronary Stent on RX System (P110004).

X-Rock: Recall - Undeclared Drug Ingredient

April 25, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

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

Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall – Doctors may receive a falsely low result

April 24, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

Customers should immediately discontinue use of any affected product.

Class I Medical Device Recall: Roche Diagnostics Operations, Inc., Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays

April 24, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

With certain types of plasma samples, doctors may receive a falsely low result (up to a maximum of 50% lower than the actual concentration of Troponin I). These incorrect results may cause serious adverse health consequences, including death.

NIST Panel: FDA Should Regulate Device Cybersecurity, Hacking Risks

April 20, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

The potential for hacking into software-operated medical devices could pose a serious patient safety risk, a board convened by the National Institute of Standards and Technology (NIST) maintains.

MDUFA: Despite Broad Agreement, 510(k) Safety Concerns Remain

April 20, 2012 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Stakeholders agree on the majority of the Medical Device User Fee Act (MDUFA) reauthorization legislation now before Congress, but that didn’t make a House health subcommittee hearing on device and drug user fees smooth sailing.

Aliskiren-containing Medications: Drug Safety Comunication - New Warning and Contraindication

April 20, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

Risk of renal impairment, hypotension, and hyperkalemia with concomitant use of aliskiren with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme inhibitors (ACEIs) in patients with diabetes.

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