All Blog Posts Tagged 'US' (12)

Global Supply Chain Regulatory Compliance

Global supply chain regulatory compliance has become more important than ever before because of the confluence of a number of factors. As globalization becomes inevitable and inescapable, the global supply chain is one of the core arenas in which it plays out. The outgrowth brought about…

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Added by John Robinson on January 23, 2018 at 5:33am — No Comments

Aspects of Regulatory History in the US

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…

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Added by John Robinson on January 8, 2018 at 5:22am — No Comments

FDA Warning Letters – an understanding

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…

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Added by John Robinson on January 3, 2018 at 4:50am — No Comments

Tougher FDA import rules are aimed at putting strict controls on imports

Tougher FDA import rules are aimed at putting strict controls on imports 3 https://globalcompliancepaneltraining.files.wordpress.com/2017/12/tougher-fda-import-rules-are-aimed-at-putting-strict-controls-on-imports-3.jpg?w=1400 1400w,…

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Added by John Robinson on December 14, 2017 at 4:30am — No Comments

The FDA's requirements for non-IND Foreign Clinical Studies

The FDA grants marketing approval for certain types of medical products whose application is the result of foreign clinical studies, provided the products and the clinical studies meet certain conditions. The types of medical products…

The FDA's requirements for non-IND Foreign Clinical Studies 2

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Added by John Robinson on December 11, 2017 at 5:41am — No Comments

The Investigational New Drug Applications mechanism in the USA

The Investigational New Drug Applications mechanism in the USA.jpg https://globalcompliancepaneltraining.files.wordpress.com/2017/12/the-investigational-new-drug-applications-mechanism-in-the-usa.jpg?w=866&h=650 866w,…

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Added by John Robinson on December 8, 2017 at 5:40am — No Comments

FDA holds Cosmetic Manufacturers & distributors responsible for the safety and quality of their Cosmetics

Testing cosmetics before the FDA does it is a sound business strategy for cosmetic manufacturers. This is why: Cosmetic manufacturers and distributors are responsible for upholding the quality and safety standards set out by the FDA. This is a legal requirement on the part of players in the cosmetics industry. In order to ensure compliance…

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Added by Adam Fleming on June 7, 2017 at 6:11am — No Comments

Implementing the Final FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

The FDA’s Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food, which was passed on April 6, 2016, has now become final. This is the latest in a series of as many as seven rules that have been getting legislated from January 2013 with the intention of creating a modern, risk-based framework that ensures food…

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Added by Adam Fleming on May 30, 2017 at 5:54am — No Comments

Regulating Nanotechnology in food

Nanotechnology, a part of Quantum Physics (QP), is growing fast and has myriad uses. Nanotechnology is all about size and self-assembly. While QP deals with subatomic particles and waves; Nano relates to the atomic and molecular level. Atomic behavior and properties get dramatically changed at the Nano level. Of note are properties such as color change due to refraction of light. Gold, packaging and chemistry are some of the well-known areas into which…

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Added by Roger Steven on November 25, 2016 at 4:50am — No Comments

Workplace Safety Regulations

Workplace Safety Regulations :

workplace-safety

Workplace safety is a matter of grave importance to any organization. Ensuring the safety of workers is a primary goal of most countries, no matter which kind of political system or setup they have. This is because almost no workplace is free from some or another kind of hazard. These workplaces could be as varied as hospitals, construction sites, engineering plants or agriculture and many more.

Governments the world…

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Added by Roger Steven on May 30, 2016 at 3:50am — No Comments

Understanding Medical Identity Theft and ways of preventing it

Understanding Medical Identity Theft and ways of preventing it

Medical Identity Theft is a common phenomenon in today's situation, where most health records are digitized. Although a lot of precaution goes into the security and protection of these records, Medical Identity Theft is a cause for worry.

The most common types of data that are stolen are Social Security Number (SSN), name and the Medicare number, the most potent tools with which to…

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Added by Roger Steven on May 19, 2016 at 7:55am — No Comments

Misconception – The remarkable medical scientific advances are rapidly made available to the care delivery system.

We should so hope but often that it is just not the case.

Laparoscopic surgery took medicine by storm 20 years ago but some new technologies of great value are slow to be adopted, such as simulation for teaching procedures rather than learning by practicing on the patient. Sometimes it is because the old way is “the way we have always done it” and sometimes it is because those holding the purse strings just do not appreciate the underlying value. Laparoscopic surgery got patients out… Continue

Added by Stephen C Schimpff on December 16, 2009 at 5:20pm — No Comments