The establishment of the initial safety of a drug is the primary reason for which early clinical trials are conducted. Phase I of drug development consists of:
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The establishment of the initial safety of a drug is the primary reason for which early clinical trials are conducted. Phase I of drug development consists of:
Added by John Robinson on May 9, 2017 at 6:04am — No Comments
Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.
The ICH tripartite-harmonized ICH…
ContinueAdded by John Robinson on May 3, 2017 at 6:18am — No Comments
A n internal audit program of an organization’s Quality Management Systems is a core requirement from both the ISO and the FDA. At its barest, an internal audit system can be understood to be an assessment or inspection of an organization’s Quality System. Audits are a very beneficial and positive tool for continually ensuring that an organization’s internal management…
ContinueAdded by John Robinson on May 3, 2017 at 5:55am — No Comments
Added by John Robinson on April 27, 2017 at 5:50am — No Comments
GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products.
Quality is a great concern for a manufacturer and consumer of any product. To ensure that quality is maintained across a variety of products ranging from foods to pharmaceutical products; a few guidelines are required. These guidelines…
Added by John Robinson on April 26, 2017 at 8:06am — No Comments
Added by John Robinson on April 25, 2017 at 6:18am — No Comments
Packaging and labeling of commercial and clinical products are very important aspects to an organization involved in a business that relates to these products. While the packaging and labeling of commercial products is important, it is more so with clinical products, because these products play an important role in a clinical trial and also in the very life of a patient or subject.
Commercial products have their own value over time. The FDA has guidances for…
Added by Adam Fleming on April 17, 2017 at 8:42am — No Comments
Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.
The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard…
Added by Adam Fleming on March 28, 2017 at 9:06am — No Comments
Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?…
Added by Adam Fleming on March 24, 2017 at 6:31am — No Comments
Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.…
Added by Adam Fleming on March 16, 2017 at 6:00am — No Comments
The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EU’s regulatory…
ContinueAdded by John Robinson on February 13, 2017 at 7:29am — No Comments
After carrying out the initial preclinical studies, drug manufacturers need to implement cGMP quality systems and risk management approaches during commercial development and operations in order to be able to meet the requirements of the FDA’s current Good Manufacturing Practice (cGMP), which are contained in and are governed by regulations 21 CFR parts 210 and 211.
The FDA’s guidance on cGMP quality systems and risk management approaches is meant to help drug manufacturers implement…
ContinueAdded by Adam Fleming on February 10, 2017 at 6:08am — No Comments
Overview:
Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with…
ContinueAdded by John Robinson on February 1, 2017 at 4:55am — No Comments
A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of the global market, and is expected to grow by over 20 percent by 2016.
While many…
Added by John Robinson on January 23, 2017 at 7:46am — No Comments
Japan is the world's third largest market for medical devices, after the US and Europe. Ironically, many of the world's medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing through the regulatory maze! The regulatory filing requirements for medical devices in Japan are…
ContinueAdded by John Robinson on January 12, 2017 at 4:51am — No Comments
In July 2010, the Obama administration chalked out new Electronic Health Record Standards. These Electronic Health Record Standards were a major improvisation on the standards that existed till then. The idea behind revising the existing Standards is to…
Added by Roger Steven on January 4, 2017 at 7:00am — No Comments
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…
ContinueAdded by Roger Steven on November 25, 2016 at 4:50am — No Comments
Compared to bigger actions, Recalls, 483s, Warning Letters and consent decrees are only some of the milder parts of punishments that the FDA could impose on a medical device company that fails to meet regulatory requirements. The bigger actions can include seizure, injunction, and civil money penalties. The Park Doctrine allows executives to even be sentenced to prison.
In the…
Added by Adam Fleming on November 22, 2016 at 4:50am — No Comments
A medical device recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls are made when a) a medical device is defective; b) when it could be a risk to health, or c) when it is both defective and a risk to health.…
Added by Adam Fleming on November 11, 2016 at 4:39am — No Comments
Annual registration is a requirement for any device firm, establishment or facility whose business relates to the production and distribution of medical devices intended for use in the US in some or another way.
Such business establishments have to register with the FDA and also need to list the devices that are made there and the activities that are performed on those devices.…
Added by Adam Fleming on October 20, 2016 at 5:59am — No Comments
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