FDA Breaks New Ground With First Approved Gene Therapy for Cancer

When oncologist Dr. Carl June heard the Food and Drug Administration’s decision to bring the first gene therapy to market in the US, he pinched himself, hard. “It was so improbable that this would ever be a commercially approved therapy,” he said, voice breaking with emotion. June was referring to a revolutionary cancer therapy that […]

FDA advisors give a thumbs-up to GlaxoSmithKline’s shingles vaccine

GlaxoSmithKline’s shingles Shingrix vaccine received an unanimous vote of support by a Food and Drug Administration advisory committee Wednesday on safety and effectiveness to be used in adults 50 and older. A decision by the FDA to commercialize Shingrix is expected later this year. The agency usually follows the recommendations of its advisory panels. GSK […]

The importance of meeting Supplier Management criteria

Meeting the supplier management criteria set out by the FDA, the ISO and the QSR regulations is mandatory for the regulated industries. The qualification and assessment of suppliers is binding for the regulated industries. Being in compliance with the requirements for supplier management set out by the FDA and by the ISO and QSR standards […]

Navigating the nuances of the Internet of Medical Things

Earlier this year, Gartner released a forecast for the Internet of Things (IoT)predicting that 8.4 billion connected things will be in use worldwide in 2017 and that total spending on endpoints and services will reach almost $2 trillion this year. This forecast is certainly encouraging, but due to the prevalence and influence of the Internet of […]

Don’t miss out! Offer @ $10 – Online Professional Courses

This is a great deal. What else does one call this offer $10 deal to enhance professional skill from GlobalCompliancePanel? Wait. We are talking about $10, but did we tell you what you get for $10? Did you think it is the cost of registration for the event? Well, be prepared to get proven wrong […]

Learn any professional courses for $10 only

Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10 each. Regulatory compliance learning, that vital ingredient needed for professionals in any area of regulatory compliance, is […]

Healthcare Compliance Professional Courses @ 10$ from GlobalCompliancePanel

Healthcare professionals now have a stronger reason than ever before to enroll for professional learning courses and upgrade their knowledge. GlobalCompliancePanel, a highly reputable provider of professional trainings for all the areas of regulatory compliance, will offer a pick of their healthcare compliance courses for just $10. Healthcare professionals have always been flocking to GlobalCompliancePanel […]

It is important and necessary to document Software for FDA Submissions

Software project management has an important tool in the Agile methodology. The Agile methodology developed as a product of the gradual efforts at arriving at a team based methodology of iterative software development. Because of its close association with software, in terms of suitability; Agile is to software development what Lean is to manufacturing. Among […]

Effective legal writing skills are essential for FDA submissions

professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with FDA

Quality Assurance Auditing for FDA-regulated industries

An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A Quality Assurance audit should also ensure that the […]