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The Food and Drug Administration recently proposed recommendations to Congress that would broaden and upgrade the agency’s drug safety plan, increase resources for television advertising review and improve drug development processes. The recommendations are part of the reauthorization…
A Food and Drug Administration senior scientist will be the next chairman for the agency’s Global Harmonization Task Force, which was established as an international effort to improve the quality of medical devices and regulatory systems. Dr. Larry Kessler is director of the office of…
Pharmatech Associates Inc. has established a Regulatory Compliance Group that’s designed to help the consultancy’s clients ensure long-term drug development compliance with Food and Drug Administration regulations. The RCG’s team members include former FDA employees who have extensive…
Solectron Corp. will host an upcoming seminar on the effect of the restriction of hazardous substances (RoHS) directive on American medical device makers. RoHS is a European requirement that prohibits the marketing of electronic and electrical equipment that contains hazardous substances—…
COLA, a clinical laboratory education and consultation accreditation organization, recently received renewed approval from the Centers for Medicare and Medicaid Services (CMS) to accredit laboratories to meet requirements set by the Clinical Laboratory Improvement Amendments. A…
Siemens Medical Solutions recently completed the EUR 4.2 billion ($5.5 billion) acquisition of Bayer Healthcare’s diagnostic division and merged it with Diagnostic Products Corp., creating Siemens Medical Solutions Diagnostics.The new wholly owned subsidiary of Siemens Medical Solutions…
Abbott Laboratories has completed its acquisition of Kos Pharmaceuticals Inc., which specializes in treatments for cardiovascular, metabolic and respiratory diseases, and is now a wholly owned subsidiary of Abbott Labs. Abbott reports that the acquisition broadens its portfolio of products…
The Pharmaceutical Research and Manufacturers of America (PhRMA) recently kicked off a multimedia campaign to raise public awareness of diabetes. Nearly 21 million Americans know they have diabetes, and as many as 6.2 million more have it and don’t know that they have it. The purpose of…
Pharmaceutical services company i3 has entered the next phase of its global expansion which includes organic and acquired growth in India, Latin America and Europe. Coupled with acquisitions in Canada and Asia Pacific that i3 made earlier this year, the additions will help i3’s…
Three out of four life sciences companies polled in a recent survey said that their current documentation practices are inefficient. The survey was conducted in November and focused on key areas of life sciences firms that are heavily involved with complex documentation practices,…
Heartbeat Software Inc. has named Six Sigma Black Belt Irena Petsche its new vice president for professional services. Heartbeat Software is a provider of software for the life sciences industry. Petsche has 20 years’ experience in the software industry and was most recently director of…
The current research and development of dozens of major cancer therapies will spur enormous sales potential in the market over the next 15 years, according to a study by Pharmacor and Decision Resources Inc. The report says that five new classes of cancer drugs will jointly account for…
Lonza Group AG recently bought Cambrex Corp.’s bioproducts and biopharma businesses. Cambrex’ bioproducts business manufactures and markets research, therapeutic and analytical testing products based on cell biology for drug discovery and biotherapeutic manufacturing. The biopharma segment…
Medicare beneficiaries previously without drug coverage significantly reduced their out-of-pocket prescription costs and now have better access to medication because of the Part D drug benefit added to Medicare last year. Those were the findings of a study conducted by the Amundsen Group…
Pharma IQ, a division of the International Quality and Productivity Center, will host a conference that will focus on simplified documentation for pharmaceutical professionals. Documentation & Paperless Automation will be held Dec. 11–13 at the Doubletree Hotel in Philadelphia. It…
The Food and Drug Administration recently named Orion Registrar Inc. a member of its Inspection by Accredited Persons Program (IAP). The designation will let Orion Registrar perform federally mandated product safety and quality system inspections of eligible medical-device manufacturers.…
The National Committee for Quality Assurance has announced that 12 software vendors are seeking certification for its Health Plan Employer Data and Information Set (HEDIS) program. HEDIS uses automated testing to validate software designed to sift through health plan databases, collect…
AssurX Inc. recently released CATSWeb Complaints Management & Regulatory Reporting System, its next-generation suite for the medical device manufacturing industry. A comprehensive solution, CATSWeb Complaints Management & Regulatory Reporting features solutions for business-…
LaBarge Inc., an electronics manufacturer for regulated technology organizations, recently achieved registration to ISO 13485. The certification was issued to the company’s Pittsburgh manufacturing facility, which is also registered to ISO 9001. The new registration to ISO 13485 will…
An upcoming regulatory affairs conference will be held in Paris with focus on current registration procedures in the European pharmaceutical market. Key topics to be discussed at the event include centralized and decentralized procedures, mutual-recognition procedures, business-opportunity…
AssurX Inc. recently released CATSWeb Complaints Management & Regulatory Reporting System, its next-generation suite for the medical device manufacturing industry. A comprehensive solution, CATSWeb Complaints Management & Regulatory Reporting features solutions for business-…
California’s biomedical industry has grown significantly in recent years and is one of the biggest employers in the state and the second-largest contributor to its high-technology economy, according to new research. The research was performed by the California Healthcare Institute and…
An upcoming seminar will introduce basic statistical concepts fundamental to clinical research for professionals who don’t have a lot of statistical experience. “Clinical Statistics for Nonstatisticians” will be held Oct. 16–17 at the Renaissance Prague Hotel in Prague, Czech Republic;…
Kevin Sharer recently became the chairman of the board of the Pharmaceutical Research and Manufacturers of America. Sharer is chairman and CEO of Amgen Inc. He replaces Peter R. Dolan as PhRMA chairman, who recently resigned from the position. Sharer will be responsible for leading and…
National Quality Assurance USA Inc. recently received accreditation to ISO 13485 from ANSI-ASQ National Accreditation Board (ANAB). ISO 13485 relates to requirements for the production of medical devices and related services. It’s based on the more generalized quality management…
