The FDA has recently published the final rule implementing section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule provides the FDA with an administrative process for the destruction of certain drugs refused admission to the United States. Many of these drugs come into the United States via international mail. […]
The Pharma and Medical device industry is well informed on the changes being implemented for better device identification and issue tracking known as the UDI ruling. The first wave of requirements for Class III devices is now behind us and Med Device Online sat down with Jay Crowley, VP and UDI Practice Lead at USDM […]
The FDA is continually looking to improve not only the safety of food and drug manufacturing but also to provide a clear understanding of these products to consumers. The FDA is proposing manufacturers implement labeling changes that identify natural sugars and those added. While including the amount of natural and artificial sugars in a product […]
Counterfeit drugs have become a growing issue in the Medical Manufacturing industry and as technology advances we are seeing more and more occurrences. We have addressed in previous posts the major risks in counterfeit products and how they can have a severe impact on the consumer. We rely on the integrity of the drug supply […]
In September of 2013 the Unique Device Identification (UDI) Ruling was put into action responding to the demand for more clarity, understanding and an easier way to update medical devices. Manufacturer’s have been implementing this ruling into their processes and come September 24, 2015 the second deadline will be put into action. Non-class III implantable, […]
Drug Manufacturers need to provide customers with vital information on their product labels such as product ingredients and the possible side effects of the product. This information has become a top priority with any drug manufacturer. Unfortunately we have seen many incidents where products did not contain the proper warnings and the outcomes can be […]
The future of RFID tagging is looking more promising than ever. The RFID Journal expects the industry to reach over $5.4 Billion by 2020. A unique story we discovered on RFID Journal’s site was one that came from the operating rooms at the University of Tennessee Medical Center; they had implemented the tracking of consumable […]
It has been over 20 years since the Nutrition Labeling and Education Act was passed requiring that all foods contain facts on the product labeling to promote education and health awareness when choosing products. After numerous petitions for an updated Nutrition Facts label, a proposal was made last spring and is in the final stages […]