fda News

Christopher P. Austin, M.D., Scientific Director, NIH Center for Translational Therapeutics, will deliver the keynote presentation at CHI’s Predictive Functional Human Tissue Models conference scheduled on November 17-18, 2011, Boston, MA.

Firm obtains FDA 510(k) clearances with assistance from Emergo Group

MediPurpose also announced that its expanding MediPlus(tm) advanced wound care product portfolio now includes Foam Ag, Comfort Foam Ag and Super Foam Ag dressings

3 Boys Farm a Hydroponic Organic Greenhouse operation in Ruskin Florida discovered ScoringAg.com is the only complete database available which works for the requirements of the COOL law, FSMA and FDA 2002 Bioterrorism Law provides full traceability.

Critical information that dietary supplement manufacturers must know in order to meet the FDA's good manufacturing practices “compliance paradigm” is detailed in a free white paper from Microtest Laboratories.

Jewish Lawyers network Announces yet another helpline for people having complications with a drug medical device or orthopedic device. Now added to the helplines is a support group for diabetics experiencing side effects from Actos

Read about these 3 reasons why you should do your homework on the health industry.

The Cooley's Anemia Foundation endorses recommendation of Oncologic Drugs Advisory Committee for FDA to approve oral chelator Ferriprox.

Radient Pharmaceuticals a developer and marketer of In Vitro Diagnostic (IVD) cancer tests, today announced it has filed for patent protection for its proprietary Onko-Sure(R) cancer test in Australia and New Zealand.

This seminar will discuss FDA requirements for computer system validation and will go through all steps for implementation.

This seminar will provide more that 20 examples of recent FDA warning letters and give clear recommendations for corrective and preventive actions.

This seminar will provide all information and tools on how to qualify network infrastructure for FDA compliance.

Integrative Therapeutics Announces The B.E.S.T. Story Ever Told Winners and Donates $2000 to the American Association of Naturopathic Physicians

This course will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data,

The Association of Clinical Researchers and Educators (ACRE) today announced its support for reforms to the Food and Drug Administration’s (FDA) conflict of interest standards.

Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, or what procedures are required and how to implement GLP regulations.

Do you trust the FDA? Sometimes the things they do can affect you in the wrong way. Read up on what to look out for.

Enforcement of HIPAA regulations is being stepped up and new fines and penalties make being ready for an audit in advance essential.

Transportation software provider, IES, Ltd., is the first Ocean AMS service provider to successfully pass the testing requirements for M1 and transmit data to the ACE (Automated Commercial Environment) portal.

Because of severe manipulations of computerized laboratory data by industry FDA inspectors focus on integrity and security of electronic records.This seminar will provide all information on how to demonstrate integrity and security of laboratory data

Visitors to the Interpack 2011 exhibition in Dϋsseldorf were given the opportunity to attend a series of special in-house seminars presented by pharmaceutical freeze dryer manufacturer GEA Lyophil.

Injury lawyers Network Announces a vaginal mesh helpline monitered by a female MSW. Injury Lawyer Networks team feels that a female Social worker is in the position to offer help,support and guidance to women facing hope turned to pain and misery

Cigarette companies claiming that it's unconstitutional to require them to advise the public with graphic health warnings seem to forget that this is exactly what happened more than 40 years ago

This webinar provides step by step instructions on how to design and manage a CAPA system that meets and exceeds compliance requirements

FDA-mandated post-market studies are coming. Phase IV studies are likely to be complex in design and large in scale (possibly 500,000 patients per arm), with exacting endpoints, and obligatory. The FDA appears to be abandoning a long-standing policy

This Project Management training for FDA Regulated Companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage.

At a German cheese producer, glass-free pH sensors from METTLER TOLEDO are being successfully used to control cultivation of starter culture in fermentation reactors. The sensor fully meets strict process safety requirements.

This summit (part of CHI's Third Annual Immunogenicity Summit) is scheduled for November 17-18, 2011 at the DoubleTree Hotel in Bethesda, MD.

This webinar will discuss current regulatory and quality requirements for reduced testing of components used in pharmaceuticals and medical devices. Reduced testing will be viewed from current industry practice, the regulations,

"Attendees will recieve a complimentary e-book of " How to write standard operating procedures and work Instructions", published by the Instructor in 2010.The e-book will be send out to attendees after the webinar.

This summit (part of CHI's Third Annual Immunogenicity Summit) is scheduled for November 16-17, 2011 at the DoubleTree Hotel in Bethesda, MD.

Domain Surgical, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its FMwand(TM) Ferromagnetic Surgical System for soft tissue cutting and coagulation.

This Food Safety Modernization Act training will provide an introduction to and summarize the key provisions of FSMA. The implementation schedule and potential expectations for food manufacturers and processors will also be outlined.

At CHI's Companion Diagnostics as an Integral Part of Personalized Medicine conference on Aug. 24-25 in D.C., national and global experts Stafford O'Kelly of Abbott Molecular and Richard Ding of bioMerieux, host keynote session.

"Attendees will recieve a complimentary e-book of " How to write standard operating procedures and work Instructions", published by the Instructor in 2010.The e-book will be send out to attendees after the webinar.

Who will benefit: Quality Control Laboratory Manager Warehousing Purchasing Managers Procurement Managers Laboratory Analyst Cost Accounting

ReBuilder Builder Medical Technologies, Inc. announced today that it has entered negotiations to acquire its manufacturing affiliate Medical Rebuilder, Inc. Negotiation should be completed soon with an August 1, 2011 closing date.

ReBuilder Has Contracted With A National Billing Company Experienced In Medicare Billing Procedures Which Lends A Degree Of Enhanced Professionalism And Capability In The Marketplace.

This training will outline practical steps to design medical device software that does not compromise on performance reliability and patient safety, thereby preventing product recalls.

This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. We will discuss the best ways to document customer feedback, what constitutes a complaint, what do with "non-complaint" feedback.

New Pharmaceuticals market report from Datamonitor: "R&D Trends: Systemic Lupus Erythematosus - Benlysta's FDA approval provides hope for disease treatment, future trial design, and other pipeline candidates"

An examination of publicly available FDA data by Emergo Group on 510(k) clearances over the last five years indicates that 80% of devices receive clearance within six months.

On Tuesday, the Food and Drug Administration [FDA] will announce what the new enhanced warnings on cigarette packs will look like. A very recent comprehensive report provides the best available information for the media and others.

MedTech announced support for Competitiveness Agenda released by AdvaMed on June 6, 2011; MedTech's 2011 Annual Conference, Sept. 13 in Rochester, NY, will address the subjects of collaboration and competitiveness.

The seminar will train companies in FDA regulated industries on proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.

The seminar will serve regulatory and quality professionals in Medical Device companies by helping them create effective Risk Management and Quality Management Systems.

This 21 CFR Part 11 webinar/training will discuss on the technical details required by technical personnel to understand, communicate and implement part 11 compliance in to computer systems regulated by FDA.

The FDA has ramped up surveillance and we have seen an increase in the number of warning letters issued to manufacturers.

Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study.

Fuerst Ittleman, a Miami, Florida FDA Law firm, launched a website