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Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment

September 1, 2011 12:31 pm | by U.S. Food & Drug Administration | News | Comments

Reclast should not be used in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment.

Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions

September 1, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

Reports of hypersensitivity reactions, including anaphylaxis (a life-threatening allergic reaction), angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash.

CDRH Learn (Spanish): 510(k) Third Party Review Online Video Presentation and Printable Slide Presentation

August 30, 2011 11:31 am | by U.S. Food & Drug Administration | News | Comments

510(k) Third Party Review Online Video Presentation and Printable Slide Presentation in Spanish

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Industry Downplays Device Hacking Fears As GAO Mulls Investigation

August 26, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Fears of hackers compromising implantable devices are unfounded, industry says.

High-Cost, High-Volume DME to See Competitive Federal Bidding

August 26, 2011 1:30 pm | by U.S. Food & Drug Administration | News | Comments

Competitive bidding will widen to the national stage for federal purchases of durable medical equipment (DME) and prosthetics, orthotics and supplies, the Centers for Medicare & Medicaid Services (CMS) said Friday.

Life-Threatening Injuries Associated with the ShoulderFlex Massager

August 25, 2011 3:31 pm | by U.S. Food & Drug Administration | News | Comments

The ShoulderFlex Massager, distributed by King International in Beaverton, OR, is a personal massage device designed for home use to provide deep tissue massage to the neck, shoulder and back while the user lies on a flat surface.

Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses

August 24, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

Citalopram should no longer be prescribed at doses greater than 40 mg per day.

Two-day Tissue Adhesives / Soft Tissue Workshop / Symposium, September 26-27, 2011

August 22, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

The FDA is announcing a Workshop to facilitate medical device innovation with the focus on tissue adhesive materials. In the last 20 years there has been an explosion in the number of biomaterials being used as adhesives. There is incredible variation..

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Summary Information for: Propel?

August 19, 2011 9:31 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Propel? (P100044).

Consumer Information on: Propel - P100044

August 19, 2011 9:31 am | by U.S. Food & Drug Administration | News | Comments

The Propel sinus implant is a temporary, self-absorbing implant designed to keep the spaces within and around the sinuses open following sinus surgery. The Propel sinus implant is manufactured from a synthetic material which is absorbed by the body over 4

PMA Final Decisions for June 2011

August 18, 2011 6:31 am | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for June 2011.

Draft Guidance for Industry and Food and Drug Administration Staff - Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act

August 16, 2011 5:31 am | by U.S. Food & Drug Administration | News | Comments

Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act) is one means by which the FDA can obtain additional safety and/or effectiveness data for a device after it has been cleared through the premarket...

FDA Pushes Registry Data to Help Meet Postmarket Requirements

August 12, 2011 4:33 pm | by U.S. Food & Drug Administration | News | Comments

CDRH is pushing a proposal to increase the use of registries to help meet device postmarket surveillance requirements.

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FDA May Require Supplier Quality Agreements in Upcoming Guidance

August 12, 2011 4:32 pm | by U.S. Food & Drug Administration | News | Comments

The FDA is considering requiring quality agreements between medical product manufacturers and their suppliers as part of its push for tighter control of the supply chain, an FDA consumer safety officer says.

Public Workshop - Mobile Medical Applications Draft Guidance, September 12-13, 2011

August 12, 2011 7:31 am | by U.S. Food & Drug Administration | News | Comments

The FDA on July 19, 2011 announced it is seeking input on its oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications (apps) that are designed for use on smartphones and other mobile...

Public Meeting - Recommendations Proposed in Institute of Medicine Report: Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years, Septembe...

August 12, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

The purpose of the meeting is to encourage public comment on the recommendations proposed in the Institute of Medicine (IOM) report.

Minutes from Stakeholder Meeting on MDUFA III Reauthorization, July 27, 2011

August 11, 2011 5:32 am | by U.S. Food & Drug Administration | News | Comments

FDA provided an update of FDA?s discussions with Industry, including details regarding the July 15, 2011 meeting with Industry. FDA noted that the Agency had also met with Industry again on July 26, 2011. FDA answered questions from stakeholders...

FDA / NHLBI / NSF Workshop on Computer Methods for Medical Devices: Validation of Computer with Nonclinical Models, September 7-9, 2011

August 11, 2011 5:32 am | by U.S. Food & Drug Administration | News | Comments

The meeting will be held on September 7-9, 2011 from 9:00 a.m. to 5:00 p.m. and an optional session (see agenda) will be held on September 6, 2011 from 1:00 p.m. - 5:30 p.m.

Important Information on the Medical Device User Fee Rates for FY2012

August 5, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

This letter is to notify you of the fiscal year 2012, (October 1, 2011-September 30, 2012), fee rates and payment procedures for medical device user fees payable to the United States Food and Drug Administration, (US FDA).

Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency

August 4, 2011 5:31 am | by U.S. Food & Drug Administration | News | Comments

Some vials may not maintain potency throughout their shelf-life, which may lead to reduced effectiveness.

GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH): Class I Recall

August 3, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

HCH device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.

Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter: Class I Recall

August 3, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

Reports of breakage and/or separation of the stylet.

Class I Medical Device Recall: Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter

August 3, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

Arrow International Inc. received complaints indicating breakage and/or separation of the stylet within the Arrow NextStep Antegrade Catheters.

Minutes From Negotiation Meeting on MDUFA III Reauthorization: July 15, 2011

August 2, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments

To provide context for FDA's proposed approach to mitigate program uncertainties and advance negotiations, FDA started by summarizing the status of where MDUFA reauthorization discussions stand. From January through April, FDA provided more data and...

Summary Information for: VITROS Immunodiagnostic Products Anti-HBe Reagent Pack, VITROS Immunodiagnostic Products Anti-HBe Calibrator, and VITROS Immunodiagnostic Products Ant...

August 1, 2011 9:32 pm | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for VITROS Immunodiagnostic Products Anti-HBe Reagent Pack, VITROS Immunodiagnostic Products Anti-HBe Calibrator, and VITROS Immunodiagnostic Products Anti-HBe Controls (P100001).

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