Press Releases with tag "FDA."



Valuable Scientific Discussions At The Third International DDI Workshop At Marbach Castle, Germany i-Newswire, 2012-05-16
The organisation team of the 3rd International DDI (drug-drug interactions) Workshop has expressed great satisfaction with the course of the scientific meeting. The participants of the DDI Workshop commended the high scientific level of the workshop.

PRISYM ID to Exhibit Best-of-Breed Labeling Solution at the Medical Design & Manufacturing East Conference 2012 i-Newswire, 2012-05-15
PRISYM ID announce they will be exhibiting at the Medical Design & Manufacturing (MD&M) East Conference next week.

Nobledrugstore Offers Free Methotrexate To Help Ease US Shortage Crisis i-Newswire, 2012-03-16
Nobledrugstore is always working to develop social initiatives, and regularly contributes in areas of need. In light of the current situation, Nobledrugstore will provide Methotrexate for free.

K2M Expands Complex Spine Product Offering with 510(k) Clearance for SANTORINI™ Corpectomy Cage Systems i-Newswire, 2012-03-01
K2M, Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the SANTORINI™ Corpectomy Cage Systems.

FDA Clears ASI’s GenASIs Advanced Imaging for HER-2/neu Analysis i-Newswire, 2012-02-20
ASI’s GenASIs automated scanning and image analysis system for detection and quantifying chromosome 17 and the HER-2/neu gene has been cleared by the United States Food and Drug Administration (FDA) for marketing in the US.

FDA Clears ASI’s GenASIs Advanced Imaging for UroVysion Analysis i-Newswire, 2012-01-31
GenASIs Scan & Analysis cleared for FISH Detection and Analysis of chromosomal abnormalities in urine specimens

Xeomin Alternative To Botox i-Newswire, 2011-12-20
Dr. Sarmela Sunder, Sunder Plastic Surgery Is One Of The First Facial Plastic Surgeons To Offer Xeomin, A New FDA Approved Alternative To Botox

Cardio Renew Satisfies FDA Requirements for Website Content i-Newswire, 2011-10-25
Cardio Renew has addressed information on website to comply with FDA standards.

Food Safety Expert Speaks at ProcessPro Client Connect Conference i-Newswire, 2011-10-18
Dr. Acheson speaks about Food Safety Modernization Act at Client Connect.

New White Paper for Dietary Supplement Manufacturers Provides How-to for New FDA Compliance Paradigm i-Newswire, 2011-09-26
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 at http://www.microtestlabs.com/dietarypaper.

Former Global Regulatory Chief Laurie Smaldone, MD, Tapped as PharmApprove President i-Newswire, 2011-09-16
Dr. Laurie Smaldone joins Princeton-based strategic regulatory communications firm, PharmApprove, as President

DocuWare 5.1c Meets Guidelines of U.S. Food and Drug Administration i-Newswire, 2011-08-17
DocuWare, document management specialists, announces their latest version of DocuWare 5 continues its legacy of compliance with US Food and Drug Administration guidelines. The certification renewal is under FDA Title 21 CFR Part 11--held since 2006.

Jeneil Biotech, Inc. Grows Its Business with ProcessPro® Premier ERP i-Newswire, 2011-07-21
Jeneil Biotech, Inc. out of Milwaukee, WI selected ProcessPro Premier ERP software. Owner Dr. Gandhi is an internationally recognized expert in microbiology and dairy processing.

Information Security and Payment Card Rules: Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliancePanel i-Newswire, 2011-04-13
In this session, attendees will learn what the PCI DSS requires for protection and how the PCI DSS relates to the HIPAA Security Rule - there are substantial similarities

FDA Approves Major Breakthrough in the Treatment of Skin Cancer i-Newswire, 2011-03-25
Today marks a major advance in the fight against skin cancer, as the U.S. Food and Drug Administration (FDA) approved a new immune-based therapy for the treatment of melanoma, the leading cause of death from skin cancer.

Pete Taft, Founder of PharmApprove™, to Once Again Co-Chair FDA Advisory Committee Conference i-Newswire, 2011-03-22
Taft To Share FDA Advisory Committee Conference Lead with sanofi-aventis’s Kevin Malobisky

FDA Clinical Trial Auditing And The Due Diligence Companies Should Conduct As Part Of Their Monitoring Program - Webinar By GCP i-Newswire, 2011-03-16
The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572.

ULTRAPURE WATER Plans Conferences in Philadelphia, Singapore and Portland i-Newswire, 2011-03-12
Registration is now underway for ULTRAPURE WATER Pharma/Emerging Technologies. The conference will focus on pharmaceutical water issues and new technologies relevant to water treatment. To register visit http://www.ultrapurewater.com.

Federal Judge Lays Down The Law In Favor Of E Cigarettes? i-Newswire, 2011-03-11
The Solar Cigarette along with other E Cigarette manufacturers received great news in the FDA Vs. E Cigarette battle. The FDA was preventing shipments of the E Cigarette to the United States but a federal judge ruled otherwise.

Ultrapure Water Pharma To Cover Key Water Treatment Topics i-Newswire, 2011-03-05
ULTRAPURE WATER Pharma/Emerging Technologies will feature presentations on key topics related to successful water treatment. Attendees will have the opportunity to network and gain practical insights in pharma water treatment.

New High Blood Pressure Treatment Approved By FDA i-Newswire, 2011-02-26
The Food and Drug Administration have approved a new drug to treat high blood pressure.The FDA described the drug, Edarbi, as being more effective in lowering 24-hour blood pressure than 2 other FDA-approved hypertension drugs, Diovan & Benicar.

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel i-Newswire, 2011-02-24
This webinar will cover several recommendations to improve the hospital's Due Diligence when dispensing Schedules II through V controlled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use or diver

Documentation for IEC 60601-1 3rd Edition Compliance - Webinar By GlobalCompliancePanel i-Newswire, 2011-02-15
In this presentation we will review the certification requirements for documentation of the clauses of IEC 60601-1 Third Edition.

Efficient Computer System Validation - 10 Easy Steps - Webinar By GlobalCompliancePanel i-Newswire, 2011-02-08
This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs.

White Paper Outlines Disinfection Testing, Cleaning Validation Studies Requirements for Reusable Medical Devices i-Newswire, 2011-02-07
A new, free white paper outlines the application of disinfection and cleaning validation requirements for reusable medical devices in line with U.S. Food and Drug Administration (FDA) regulations.



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