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Asia-Pacific Cooperation Forum Aims for Device Harmonization by 2020

November 25, 2011 2:32 pm | by U.S. Food & Drug Administration | News | Comments

The Asia-Pacific Economic Cooperation (APEC) forum has agreed on a strategic plan to align regulatory approval procedures for medicines and medical devices by the end of the decade.

Ex-Synthes Execs Prison-Bound for Deaths in Unauthorized Trials

November 25, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Former executives of orthopedic devicemaker Synthes drew prison sentences for clinical trial rule violations that killed three people.

October 2011

November 25, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Monthly Safety Labeling Changes includes 48 products with revisions to Prescribing Information.

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Summary Information for: NeuRx DPS?, Diaphragm Pacing System

November 23, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for NeuRx DPS?, Diaphragm Pacing System (H100006).

Consumer Information on: Belotero Balance - P090016

November 22, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Belotero Balance is a transparent hyaluronic acid gel that is injected into facial tissue to smooth wrinkles and folds, especially around the nose and mouth. Hyaluronic acid is a protective, lubricating and binding gel that is produced naturally by the...

Summary Information for: BELOTERO Balance

November 22, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for BELOTERO Balance (P090016).

Harkin Hints 510(k) Doomsday Plan Might Be Revived Via User Fee Bill

November 18, 2011 1:32 pm | by U.S. Food & Drug Administration | News | Comments

Weeks after missing a self-imposed deadline to respond to Institute of Medicine (IOM) recommendations on the 510(k) process, CDRH Director Jeffrey Shuren told senators at a Tuesday hearing he’s unsure when the agency’s response will see daylight.

Industry Praises MDUFMA Progress, FDA Frets About Meeting Deadline

November 18, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

The device industry and the FDA are closer to an agreement on reauthorizing the Medical Device User Fee Amendments Act (MDUFMA), but chances are slim that the agency will meet the Jan. 15 goal to delivery that agreement to Congress.

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Minutes From Negotiation Meeting on MDUFA III Reauthorization, September 13, 2011

November 18, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

Industry provided a response and counter-proposal to the proposal offered by the Agency on August 24, 2011. Industry reiterated that their intent from the beginning of these negotiations has been to achieve a process that is efficient and ultimately...

Carestream Receives FDA Clearance Letter for Mobile Use of Its Vue Motion Medical Image Viewer

November 16, 2011 5:18 am | News | Comments

ROCHESTER, N.Y.--(BUSINESS WIRE)--Carestream has received a clearance letter from the U.S. Food and Drug Administration (FDA) for the use of its Vue Motion medical image viewer with mobile devices such as Apple iPads in the United States. The zero-footprint, Web-based viewer...

MedPro Safety Products Receives ISO 13485 Recertification

November 15, 2011 5:35 am | News | Comments

LEXINGTON, Ky.--(BUSINESS WIRE)--MedPro Safety Products, Inc. (OTCBB: MPSP), a leading developer of transformational technologies that enable safer medication delivery and blood collection, today announced that it has passed its ISO 13485 recertification audit.

Positive Clinical Study Results for BSP's HyperQ Technology will be reported in American Journal of Cardiology

November 15, 2011 4:56 am | News | Comments

Tel - Aviv, November 14, 2011 - BSP Biological Signal Processing Ltd. (BSP) (TASE: BSP), which develops and manufactures products for the non-invasive, accurate diagnosis of Coronary Artery Disease (CAD), recently announced the successful completion of a comprehensive clinical research study...

Over 100,000 People Urge the FDA to Issue Clear and Reasonable Guidance on the Artificial Pancreas

November 15, 2011 4:52 am | News | Comments

Washington, D.C. – Over 100,000 people throughout the country have signed a petition urging the FDA to issue clear and reasonable guidance  for development of an artificial pancreas (AP), the most revolutionary advance in treating type 1 diabetes (T1D) since the discovery of insulin.

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Virility Max: Recall - Undeclared Drug Ingredient

November 14, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

Product marketed as dietary supplement contains sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

FDA Issues Two Guidances to Boost First-In-Human Studies

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

The FDA proposes to streamline device clinical trials in a pair of draft guidances outlining requirements for early feasibility studies and explaining when a trial can begin even when there are outstanding issues with an Investigational Device Exemption (IDE) submission.

FDA, Devicemakers Want to Accelerate User Fee Talks, But Disagreement Reigns

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

Medical device industry reps and FDA officials negotiating the next user fee authorization are behind schedule and want to accelerate their progress, but those meetings remain acrimonious and the parties are still far apart on major issues.

Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (...

November 10, 2011 3:31 am | by U.S. Food & Drug Administration | News | Comments

This guidance document has been developed to promote the initiation of clinical investigations to evaluate medical devices under FDA?s Investigational Device Exemptions (IDE) regulations, Title 21 Code of Federal Regulations (CFR) Part 812.

Draft Guidance for Industry and Food and Drug Administration Staff - Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including C...

November 10, 2011 3:30 am | by U.S. Food & Drug Administration | News | Comments

This document is intended to provide guidance to FDA staff, clinicians, clinical innovators, and industry on the development and review of Investigational Device Exemption (IDE) applications for early feasibility studies of significant risk devices.

Mizuho OSI Modular Table Systems: Class I Recall - Reports of Patient Injury

November 9, 2011 10:31 am | by U.S. Food & Drug Administration | News | Comments

Potential for patient falls or unanticipated patient movement, which may result in serious injury or death.

Trilipix (fenofibric acid): Drug Safety Communication - Label Change

November 9, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

The ACCORD Lipid trial found no significant difference in the risk of a major adverse cardiac event between group treated with fenofibrate plus simvastatin compared with simvastatin alone.

Needles and Other Sharps (Safe Disposal Outside of Health Care Settings)

November 8, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

This webpage gives tips for safely disposing needles and other sharp devices that are used outside of health care settings. Patients and caregivers should keep these tips in mind when at home, at work, and while traveling.

Multiple States and Vendors Agree on Standard Health Data Connectivity Specifications

November 8, 2011 4:24 am | News | Comments

NEW YORK, Nov. 8, 2011 /PRNewswire/ -- A group of states and vendors focused on eliminating the barriers to sharing electronic health records (EHRs) today issued a set of technical specifications to standardize connections between healthcare providers, health information exchanges (HIEs)...

Minutes From Negotiation Meeting on MDUFA III Reauthorization, October 21, 2011

November 7, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

Industry's October 6, 2011 proposal allows applicants 15 days to draft pre-submission meeting minutes followed by 15 days for FDA to provide edits to the applicant?s draft minutes and 15 days for the applicant to indicate disagreement with how a...

Public Workshop - Bridging the IDEAL and TPLC Approaches for Evidence Development for Surgical Medical Devices and Procedures, December 2, 2011

November 7, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

The purpose of the public workshop is to provide a forum for discussion among FDA, governmental agencies, academia, physicians and various stakeholders to f urther refine and advance the IDEAL initiative (Idea Development Exploration, Assessment and...

CareFusion EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation

November 4, 2011 11:31 am | by U.S. Food & Drug Administration | News | Comments

Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death.

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