Skip to main content

Food Safety Bill: A major overhaul of the Food Safety System

BayBiotech.NET
The recently passed Food Safety bill is being considered to be a major overhaul of the food safety system in the United States and is considered to change the mission of the FDA, focusing it on preventing food-borne illnesses rather than reacting after an outbreak occurs.
Under this legislation, food manufacturers are required to examine their processing systems to identify possible ways that food products can become contaminated and to develop detailed plans to keep that from happening. Companies must share those plans with the F.D.A., and provide the agency with records, including product test results, showing how effectively they carry them out.

To read more about it follow the link

Comments

Popular posts from this blog

ISO Management Standards for Medical Devices

Two main ISO standards that have a direct application to Medical Device Industry are ISO 9001 and ISO 13485. While ISO 9001 is for evolving a Quality Management System for an organization, ISO 13485 has a direct application to Medical Device Industry. Although, ISO standards for a company are not a legal requirement, but provide a validation and ease of global marketing of the product.

XML backbone based eCTD Documents

BayBiotech.NET The eCTD submission requires construction of XML based backbone for the submission with strict guidelines for file name size, pdf style and hypertexting format. Although the XML based backbone is a choice for submission as it gives an advantage by making the submission independent of operating system environment, but also imposes some issues for a successful submission. In order to avoid the pitfalls and delay in response of obtaining RTF (refuse-to-file) along with the expertise in preparing high quality .pdfs for submission and expertise in XML is also required. On analyzing the various tools available in the market, my recommendation will be to use caution in using such tools without double checking the submissions and having an independent quality check of your own as such tools are still at prelim phases of development and as a sponsor you may not wish to bet your million dollar investment on a RTF. A good quality .pdf, an accurate XML coding as well as strict

Risk Based Clinical Monitoring

BayBiotech.NET FDA's recommendation of Risk Based Monitoring of Clinical Trials , as published in their Draft Guidance in August 2011. For the first time, FDA provided guidance on monitoring of clinical investigations in 1988 which was recently withdrawn, stated that the “most effective way” to monitor an investigation was to “maintain personal contact between the monitor and the investigator throughout the clinical investigation.” At the time the guidance was issued, sponsors had only limited ways to effect meaningful communication with investigators other than through on-site visits.   This guidance recommends an assessment by the sponsor for the need of 100% on-site monitoring. Such an assessment may be based on the complexity of the study protocol and not be generally applicable to all trial types. It explains the importance of remote monitoring facilitated by the use of electronic data capture system (EDC) and also emphasizes the need of the identifying critical