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05:28 EDT 23rd August 2014 | BioPortfolio

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Showing "regulation regulatory" News Articles 51 to 75 of 7,100+

Thursday 21st August 2014

The American Med Spa Association Has Launched a New Comprehensive Website Educating the Medical Spa Community On the Laws and Regulations Governing the Industry

The new user-friendly website features a more accessible format for members to obtain up-to-date information on their state's rules and regulations within the medical spa industry as well as educational programs, a member engagement platform, online job boards and more. Members create their own profile within the site, obtain guidance from marketing professionals as well as have access to HIP...

4 Questions to Ask Before Your Next Dentist Appointment

Dental laboratories in more than 40 states in the U.S. are unregulated. Restorations made at these facilities could contain harmful material that can lead to a range of health consequences for patients. Tallahassee, FL (PRWEB) August 21, 2014 Poorly-made dental restorations – whether produced in America or abroad – can lead to a range of health consequences for patients. To ensure better outc...

Newly-named to Inc. 5000, Regulatory and Quality Solutions LLC (R & Q) expands into Boston’s medical device industry market

Pittsburgh-based R & Q has officially commenced operations in the Boston area, providing best-in-class quality and regulatory solutions to the medical device industry in a region identified as a leading market. The announcement comes with R & Q’s recent achievement of being named to the 2014 Inc. 5000 list of fastest-growing private companies in America. The company is anticipating hiring approx...

Consumers Desperate For Measures To Curb Prescription Drug Abuse

CINCINNATI, Aug. 21, 2014 /PRNewswire/ -- Seventy-one percent of Americans believe the abuse of strong prescription pain medications such as OxyContin is a serious public health and safety issue in the United States, according to findings from a survey released today by Repass & Partners, a Cincinnati based research firm.   "Americans understand the severity of the prescrip...

WorkCompCentral Issues Call for Entries for Comp Laude™ Awards

Nominations are due Oct. 12 for annual awards program recognizing outstanding leadership in workers’ compensation WorkCompCentral.com is soliciting nominations for its 3rd Annual Comp Laude™ Awards, recognizing outstanding leadership in the California workers’ compensation community. “We hear so many negative things about work comp, bu...

The Zacks Analyst Blog Highlights: Achillion Pharmaceuticals, Gilead Sciences, Amgen, Roche and Biogen

CHICAGO, Aug. 21, 2014 /PRNewswire/ -- Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include the Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN-Free Report), Gilead Sciences (Nasdaq:GILD-Free Report),

MediciGlobal Appoints Dr. Linda Capsey as Vice President

PHILADELPHIA and LONDON, Aug. 21, 2014 /PRNewswire/ -- MediciGlobal Ltd., a global leader in patient recruitment and retention for clinical trials, today announced the appointment of Linda Capsey, PhD as Vice President Project Management and Innovation. With more than 20 years industry experience, Dr. Capsey joins MediciGlobal's dynamic management team as a leader in building and managing high per...

ViaCyte, Inc. Announces Signing of Rights Agreement with Janssen Research & Development LLC.

SAN DIEGO, Aug. 21, 2014 /PRNewswire/ -- ViaCyte, Inc., a privately held regenerative medicine company announced today that it has entered into a Rights Agreement with Janssen Research & Development LLC (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The agreement provides Janssen with a future right to evaluate a transaction related to the VC-01™ co...

ACI Clinical: Innovation and Savings in Data Safety Monitoring Committees

PHILADELPHIA, Aug. 21, 2014 /PRNewswire/ -- ACI Clinical (www.aciclinical.com) announces a new, standards-based platform for independent Data Monitoring Committees. Using this solution, trial sponsors can save up to 30 percent over industry standard costs and receive the same expertise that has made ACI an industry leader in committee services. Leveraging a decade of DMC experience (initia...

US Ends Probe Into AstraZeneca’s Brilinta Without Charges

The US Department of Justice has closed without charges its ten-month investigation of British-Swedish AstraZeneca revolving around the blood thinner Brilinta. The probe into what the drugmaker regards as a $3.5 billion/year potential blockbuster was...

HFS Consultants Offers Specialized ICD-10 Training for Healthcare Organizations

OAKLAND, Calif., Aug. 21, 2014 /PRNewswire/ -- Healthcare organizations seeking help with ICD-10 preparation, can find the necessary expertise with HFS Consultants' (HFS) highly regarded AHIMA Approved ICD-10 CM/PCS trainers. HFS, a management, financial, operational, regulatory, and strategic planning healthcare consulting company, offers extensive ICD-10 industry knowledge and has partici...

Pilot initiative will test tools for streamlining medtech regulatory processes

The FDA has released guidelines governing its pilot program to develop tools for streamlining the premarket review and regist -More- 

Hologic tapped to offer fracture evaluation tool in Canada, U.S.

Hologic has agreed to market in the U.S.  -More- 2014 EU Regulations Medical Devices Roadshow: Are You Prepared for Future Changes? How well are you managing today's European regulatory expectations? Are you prepared for future updates?

Ampio reports that due to temperature deviations below product specifications during shipments to the Ampion™ STEP Study clinical sites, release of data will be delayed

ENGLEWOOD, Colo., Aug. 21, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced a delay in the data analysis of the STEP Study due to the discovery by the independent Clinical Research Organization (CRO) that the study drug (both AmpionTM and the placebo) were, during shipment to the clinical sites, exposed to lower temperatures than permitted by the drug specific...

Professional Compounding Centers of America will award top poster-session winners at European Paediatric Formulation Initiative in Athens

HOUSTON, Aug. 21, 2014 /PRNewswire-USNewswire/ -- Professional Compounding Centers of America (PCCA) will recognize innovation in paediatric medicine by awarding the three best scientific presentations at the sixth European Paediatric Formulation initiative (EuPFI) conference. The Formulating Better Medicines for Children conference, held September 17 – 18 in Athens, Greece, includes do...

Novocure Announces the Submission of a Pre-Marketing Approval Application in Japan for the NovoTTF™-100A System to Treat Recurrent Glioblastoma

ST. HELIER, Jersey, Aug. 21, 2014 /PRNewswire/ -- Novocure, a commercial stage oncology company, announced today that it has submitted the registration dossier for Pre-Market Approval (PMA) of the NovoTTF-100A System to treat recurrent glioblastoma to the Japanese Pharmaceutical and Medical Device Agency (PMDA). Glioblastoma is the most common and deadly form of primary brain cancer. The dise...

US drone research hits regulatory turbulence

Federal rules ground scientists using remotely piloted aircraft at private universities.

Cyberonics Reports Fiscal 2015 First Quarter Results

HOUSTON, Aug. 21, 2014 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ:CYBX) today announced results for the quarter ended July 25, 2014.  Quarterly highlights1  Operating results for the first quarter of fiscal 2015 compared to the first quarter of fiscal 2014, and other achievements, include: Worldwide net product sales of $72.0 million, an increase of 6.8%; Strong international ne...

Lilly's Ixekizumab Superior to Etanercept and Placebo in Phase 3 Psoriasis Studies

INDIANAPOLIS, Aug. 21, 2014 /PRNewswire/ -- Ixekizumab met all primary and key secondary objectives across three pivotal studies of 3,866 patients, the largest Phase 3 moderate-to-severe plaque psoriasis program to date Ixekizumab was superior to etanercept on all measures of skin clearance in both active comparator studies Lilly plans regulatory submissions for ixekizumab in 1st half of 2015...

ITelagen Named to the Renowned 2014 Inc. 5000 List of Fastest-Growing Private Companies

For the 5th consecutive year, ITelagen is named to the Inc. 5000 List and jumps up 192 spots from 2013. Jersey City, NJ (PRWEB) August 21, 2014 ITelagen, Inc., a leading provider of healthcare IT support and system administration, including a range of support services such as professional services, training, and hosting for various industries, today, announces that the company was named to the re...

FDAnews Announces: Pre-Conference Workshop — Flawless FDA Inspection Handling and Response: A Hands-On Seminar for FDA-Regulated Companies, Oct. 22, 2014

In four hours, John Avellanet delivers proven, practical techniques for fast, flexible, flawless inspectional handling and response. Attendees will leave the session with a complete inspection SOP and an observation closure matrix, able to prove to an investigator they’re in a “state-of-control” and, if the worst happens, go from 483 observation to a coveted Untitled Letter without ever trig...

Illumina Announces Strategic Partnerships with AstraZeneca, Janssen and Sanofi to Redefine Companion Diagnostics for Oncology

Illumina, Inc. (NASDAQ:ILMN) today announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing (NGS)-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeu...

Wednesday 20th August 2014

Nutra Pharma Retains BUYINS.NET to Surveil Short Sellers and Market-Makers

CORAL SPRINGS, FL -- (Marketwired) -- 08/21/14 -- Nutra Pharma Corp (OTC: NPHC) Nutra Pharma Corp (OTC: NPHC) announced today that BUYINS.NET, http://www.buyins.net, a leading provider of Regulation SHO compliance monitoring, short sale trading statistics and market integrity surveillance, has initiated coverage on Nutra Pharma Corp after releasing the latest short sale data through August 18, 2...

Sirona Biochem Launches Global Awareness Campaign With Cousteau Ambassadors' Video

VANCOUVER, BC--(Marketwired - August 21, 2014) - Sirona Biochem Corp. (TSX VENTURE: SBM) (FRANKFURT: ZSB) launches global awareness campaign with ambassadors' video produced by the team of Jean-Michel Cousteau and Fabien Cousteau to represent their support of the glycoprotein project. "The time and effort put into this video illustrates just how dedicated the Cousteaus are to the relationship wi...

AAPS PharmSciTech: Regulatory Considerations for the Classification of Video Monitoring in Dissolution Testing

Type: Original PaperThe goal of this article is to discuss the classification of video recordings and images when applied to dissolution testing in USP apparatus 1 and 2. Three use cases are presented. The first case presents the use and classificati...


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