Tagged fda
Press Release
MedTech Group Opens in United Kingdom to Bridge USA Import/Export Market
With expertise in commercializing medical and in vitro diagnostic devices, MAE Consulting markets medical products globally and across the Atlantic -- in either direction. The new MAE office in Manchester, England is strategically located to take full advantage of the UK government's Northern Powerhouse initiative supporting innovation and the MedTech community in northwest England. Read More
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Lazarex Cancer Foundation's Founder and President Dana Dornsife Met With Greg Simon the Executive Director of the Cancer Task Force in the Office of the Vice President of the United States
The meeting highlighted Lazarex Cancer Foundation's new iMPACT pilot program, which is working to improve patient enrollment, retention, and minority member participation in oncology clinical trials especially among underserved populations. Read More
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Holistic-Vape to Launch One-of-a-Kind E-Cigarette Formula That Contains No Nicotine
As the U.S. Food and Drug Administration (FDA) releases crippling regulations for the e-cigarette industry, Holistic-Vape emerges from the vapor unaffected and poised for growth offering investors a significant investment opportunity. Read More
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CCHR Warns Parents About Stimulant Adderall Risks: Illicit Use Is "Similar to Taking Meth," According to Neurologist
International mental health watchdog Citizens Commission on Human Rights, established in 1969 by the Church of Scientology and eminent psychiatrist, Prof. Thomas Szasz, warns parents to be alert to their teen-aged children being illicitly sold the stimulant Adderall in light of recent statements by neurologist, Don Gervais, that abuse can "lead to progressive and early drug induced Parkinsonism," and that the effects on the brain are similar to taking meth. Read More
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NetZealous Successfully Completes Seminar On, "The DHF, Technical File and Design Dossier"
This seminar examined the existing and proposed requirements for the FDA's Design History File (DHF) and its derivate documents, the Device Master Record (DMR) and Device History Record (DHR). Read More
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Camargo Pharmaceutical Services Integral in Medicines360's Intrauterine Contraceptive Device FDA Approval
Camargo Pharmaceutical Services, the most experienced global strategist in the drug development industry specializing in the 505(b)(2) approval pathway, has helped Medicines360 gain FDA approval for their hormonal intrauterine contraceptive device. This intrauterine contraceptive device is important because it is a high quality product which will reach underserved women in 340B family planning clinics, and is being made available to these clinics at an affordable price of $50. Read More
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Von Vape Sits Down With Congressman Vern Buchanan's Staff to Discuss the FDA's Deeming Regulations
Last week, Von Vape had the opportunity to sit down with Congressman Vern Buchanan's staff, to discuss the FDA's "Deeming Regulations" and House Bill 2058, both of which are designed to amend the agency's regulatory authority over a variety of tobacco products. Read More
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Miacom Diagnostics GmbH Gets FDA Clearance for hemoFISH Masterpanel
miacom diagnostics GmbH, Duesseldorf, a company focused on the development and production of medical tests for the detection of acute infectious diseases, today announced the U.S. Food and Drug Administration (FDA) clearance. Read More
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INNOVUS PHARMA ENTERS $1 BILLION WORLDWIDE NASAL STEROID MARKET WITH THE ACQUISITION OF FLUTICARE(TM) (FLUTICASONE PROPIONATE NASAL) OVER THE COUNTER ("OTC") RIGHTS FROM NOVALERE
INNOVUS PHARMA ENTERS $1 BILLION WORLDWIDE NASAL STEROID MARKET WITH THE ACQUISITION OF FLUTICARE(TM) Read More
Press Release
Seminar on "Applying ISO14971:2012 and IEC62304 - A Guide to Practical Risk Management" by Markus Weber
The course will introduce the core elements of risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle. Read More
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Webinar On - Key Factors To Write An Effective Standard Operating Procedure And Work Instruction
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. Read More
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FDA Approves First Season Influenza Vaccine Manufactured Using Cell Culture Technology
The U.S.A. Food and Drug Administration announced on 21, nov. 2012 the approval of Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. Read More
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FDAnews Announces The FDA Unique Device Identification (UDI) Rule Virtual Conference, Nov. 19
The FDA Unique Device Identification (UDI) Rule It's Ready for You, Are You Ready for It? **FDAnews Virtual Conference** Nov. 19, 2013 - 10:00 a.m. - 4:00 p.m. EST www.fdanews.com/UDIVirtualPR3 Read More
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Webinar on "U.S. FDA's Strategic Priorities for 2013 and Beyond" from GlobalCompliancePanel
Each year, companies are to perform a complete review of their quality management system and its ability to meet the current GMP's. The FDA has now added a "Strategic Priorities" initiative that is aimed at assisting companies to proactively address. Read More
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Leading Informational Website For Seniors Publisher Urges FDA Extend Recognition Of 'Reciprocity' To Personal Importation
Daniel Hines says FDA has opportunity to help offset high prescription drug prices with extension of reciprocal agreements with Tier One Countries to ensure American's access to safe, affordable medicines. Read More
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SFATA Dispels Rumors and Inaccuracies Regarding Mission
The Smoke Free Alternatives Trade Association's (SFATA) recent success has created detractors who have expressed unsubstantiated concerns about SFATA's mission and objectives to advocate for and generate interest in the electronic cigarette indus Read More
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