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Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to Newborns

February 22, 2011 6:32 am | by U.S. Food & Drug Administration | News | Comments

Risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs.

FDA Down-Classifies MDDS to Class I Via Final Rule

February 18, 2011 7:30 pm | by U.S. Food & Drug Administration | News | Comments

The FDA has down-classified medical device data systems (MDDS) from Class III into Class I via a final rule, which could help manufacturers compete with IT companies in this area.

FDA Questions UK Regulator & #8217;s Data on Hip Implant Recalls(2)

February 18, 2011 5:31 pm | by U.S. Food & Drug Administration | News | Comments

Quality problems with metal-on-metal (MoM) hip replacement systems, like Johnson & Johnson (J&J)’s ASR devices, may not be as widespread as UK data indicates, the FDA says.

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Terbutaline: Label Change - Warnings Against Use for Treatment of Preterm Labor

February 17, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Potential for serious maternal heart problems and death.

Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall

February 16, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Recall due to pocket fills may result in patient harm, serious injury, and/or death due to drug overdose or underdose.

Class I Medical Device Recall: Abbott Glucose Test Strips

February 15, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

These test strips may give falsely low glucose results. False results may lead patients or health care providers to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading...

Class II Medical Device Recall: Triad Group, Triad Sterile Lubricating Jelly

February 15, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: This product may not be sterile. Patients, who are immuno-compromised, such as those with diabetes, cancer and certain other chronic diseases, may be at potential risk for infection.

FDA Finalizes Regulation for Certain Software, Hardware Used With Medical Devices

February 14, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments

Today, the FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or...

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Tra Warning Letter Cites Lack of GMP Procedures, Controls

February 11, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

An FDA inspection of Tra & Accessories found failures in its control of design, purchasing and the warehouse environment for products, resulting in a warning letter.

Breast Implant Panel Requested, FDA Oversight Questioned

February 11, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Rep. Rosa DeLauro (D-Conn.) is “strongly urging” CDRH to hold an advisory committee meeting to release all available information on 10-year postmarket study results for saline breast implants and address issues with FDA oversight of the trials.

Information on Metal-on-Metal Hip Implants

February 10, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments

Hip joint deterioration can lead to symptoms such as pain, stiffness or difficulty walking. When symptoms do not respond to conservative treatment, patients may be advised to undergo total hip replacement or hip resurfacing...

Arstasis One Access System: Class I Recall - Components May Fracture and/or Separate

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

Use of recalled product may lead to patient harm.

Federal Register: Medical Device Innovation Initiative; Request for Comments

February 9, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

The report proposes potential actions for FDA's CDRH to facilitate the development, assessment, and regulatory review of innovative medical devices.

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Federal Register: Medical Device Innovation Initiative; Public Meeting; Request for Comments

February 9, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

FDA is seeking input on a number of identified challenges associated with incentivizing innovation, and the proposed solutions. In addition, the Agency requests comments on the Innovation Pathway proposed under the report.

Public Workshop - Center for Devices and Radiological Health's Innovation Initiative, March 15, 2011

February 8, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

The purpose of the public workshop is to solicit public feedback on select actions outlined in CDRH's Medical Device Innovation Initiative (report). FDA is seeking input on a number of identified challenges associated with incentivizing innovation, and...

CDRH Medical Device Innovation Initiative

February 8, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

CDRH recognizes that transformative innovative devices typically present new scientific and regulatory challenges. The Innovation Initiative supports the development of innovative products by addressing some of the barriers that can impede a product's...

Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall - Incorrect Package Labeling

February 7, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

Patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital, which can lead to serious adverse events.

American Regent Injectable Products: Recall - Visible Particulates in Products

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

Some vials exhibit translucent visible particles consistent with glass delamination.

Guidance Gives Application Tips to PET Scan Drug Sponsors

February 4, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA has issued a draft guidance on the required content and format of applications for the drugs used in positron emission tomography (PET) diagnostic scans.

IRBs Warned for Written Procedures, Member Issues

February 4, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Two institutional review boards (IRBs) have received warning letters for failure to follow written procedures and maintain member quorums during clinical trials for devices.

Merit Prelude Short Sheath Catheter Introducer: Class I Recall - Tip May Detach During Use

February 4, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Use of recalled product may lead to arterial injury, hemorrhaging, blood clots (thrombosis), or other serious events.

Federal Register: Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop

February 4, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

This 2-day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry.

B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall - Hardware May Become Unresponsive

February 2, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

Software update may cause normal operation to stop with no visual warning signal.

Summary Information for: Arctic Front CryoCatheter System

February 1, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Arctic Front CryoCatheter System (P100010).

Summary Information for: LifeStent and LifeStent XL Vascular Stent

January 25, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for LifeStent and LifeStent XL Vascular Stent (P070014S010).

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