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When you work in an industry that is regulated by the FDA, one thing that is as certain as day and night is the fact of FDA regulation. Of course, this is as obvious as saying that solar power is derived from the sun and is as silly as asking if the FDA regulates FDA-regulated industries! The point being made is that regulation is the essence of the FDA’s existence. The FDA has been created to regulate certain industries with the intention of…
ContinueAdded by Adam Fleming on August 20, 2018 at 6:37am — No Comments
That pharmaceutical companies need to hire professionals with the requisite qualifications is beyond question. This is not only required for the smooth conduct of activities in their course of their day-to-day work, but also because the FDA has set out its requirements for the proper educational and skill set qualification of employees in this profession in 21 CFR 211.25(a).
This FDA section underlines the need for educational qualifications, training and experience to carry out their…
ContinueAdded by John Robinson on April 24, 2018 at 7:29am — No Comments
FDA consulting services are those services that are offered by independent, mostly private companies in helping to meet FDA requirements. FDA consulting services are offered to organizations that have to meet FDA regulatory requirements. Many companies across the US and many other parts of the world specialize in offering FDA consulting services and these are often the main business for these…
ContinueAdded by John Robinson on April 12, 2018 at 6:46am — No Comments
One of the chief aims of the FDA is to ensure the protection of public health and making sure that select types of organizations comply with the provisions of the Food, Drug and Cosmetic Act. It enforces these aims by conducting periodic inspections of the facilities and types of organizations that come under its purview. The FDA is empowered by the terms of the Federal Food, Drug, and Cosmetic Act, Sec. 704…
ContinueAdded by John Robinson on April 10, 2018 at 7:07am — No Comments
https://globalcompliancepaneltraining.files.wordpress.com/2018/02/it-is-important-for-organizations-to-validate-their-own-excel-spreadsheet-application.jpg?w=150 150w,…
Added by John Robinson on February 9, 2018 at 4:50am — No Comments
https://globalcompliancepaneltraining.files.wordpress.com/2018/01/the-fda-export-reform-and-enhancement-act-of-1996-a-brief-understanding-3.jpg?w=150 150w,…
Added by John Robinson on January 17, 2018 at 4:39am — No Comments
https://globalcompliancepaneltraining.files.wordpress.com/2018/01/effective-complaint-handling-guidelines-serve-as-a-basis-for-improvements-in-medical-devices1.jpg?w=150 150w" sizes="(max-width: 266px) 100vw, 266px" />Far from being frowned upon, complaints should serve as…
Added by John Robinson on January 16, 2018 at 4:44am — No Comments
Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU's regulatory body, the MDD.
Added by John Robinson on January 10, 2018 at 4:53am — No Comments
https://globalcompliancepaneltraining.files.wordpress.com/2018/01/design-control-for-medical-devices-3.jpg?w=650&h=650 650w,…
Added by John Robinson on January 9, 2018 at 4:56am — No Comments
The beginnings of all that the USFDA regulates can be traced right to the early decades of the founding of the nation. In a sense, the FDA, even if came to be called by that formal name much later; embodies the discipline and value set that the new created nation sought to represent. Regulation of all aspects of American life was deeply ingrained…
Added by John Robinson on January 8, 2018 at 5:22am — No Comments
Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent.
Good Documentation…
Added by John Robinson on January 5, 2018 at 5:06am — No Comments
Sponsors of clinical studies adapt many methods that are aimed at reducing the complexity of clinical trials. They also look for methods by which they can increase the efficacy of the results, while keeping the costs low. Risk-based monitoring is one of these methods.
How is risk-based monitoring understood?One can understand risk-based monitoring in several ways. This varied understanding is because there is no one definition or…
Added by John Robinson on January 4, 2018 at 5:04am — No Comments
As the primary regulator of the biological, healthcare, life sciences and other related industries; the FDA has power and authority over how its work is carried out. FDA Warning Letters are among the primary mediums through which it enforces its authority.
The FDA issues a Warning Letter to a company when it determines, following…
Added by John Robinson on January 3, 2018 at 4:50am — No Comments
https://globalcompliancepaneltraining.files.wordpress.com/2017/12/tougher-fda-import-rules-are-aimed-at-putting-strict-controls-on-imports-3.jpg?w=1400 1400w,…
Added by John Robinson on December 14, 2017 at 4:30am — No Comments
https://globalcompliancepaneltraining.files.wordpress.com/2017/12/the-investigational-new-drug-applications-mechanism-in-the-usa.jpg?w=866&h=650 866w,…
Added by John Robinson on December 8, 2017 at 5:40am — No Comments
Export, import and trade compliance principle is a very important guiding standard for governing trade policies and ensuring compliance with the set national, regional and global trade norms. It helps to define an organization’s adherence to the export, import and trade compliance principle laid out by the government and also offers an…
Added by John Robinson on December 4, 2017 at 4:50am — No Comments
This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. It captures some key outcomes of a multi-stakeholder dialogue (Brussels, May 2016), spearheaded by a joint effort of the Organisation for Economic Co-operation and Development (OECD) and the Department of Economy, Science and Innovation of the Flemish Government (Belgium), to help design and/or interpret regulatory…
Added by John Robinson on November 7, 2017 at 5:04am — No Comments
The Food and Drug Administration (FDA) has granted breakthrough therapy designation to GlaxoSmithKline (GSK) for its investigational B-cell mutation agent (BCMA) monoclonal antibody-drug conjugate, GSK2857916, for relapsed and refractory multiple myeloma.…
Added by John Robinson on November 7, 2017 at 5:00am — No Comments
Orkambi (lumacaftor/ivacaftor) reduced levels of the main biomarker of the lung disease cystic fibrosis and improved the nutritional status of children with the condition, according to a Phase 3 clinical trial.
The results were part of a recent update that Vertex…
Added by John Robinson on November 3, 2017 at 6:25am — No Comments
Statins should be given to thousands of children by the age of 10 under radical new NHS guidance.
GPs are being urged to identify those who have an inherited risk of high cholesterol, amid warnings that the vast majority of cases are going undetected.
Estimates suggest up to 260,000 people –…
Added by John Robinson on November 3, 2017 at 6:24am — No Comments
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