Life is a Journey..how to make the best of it!

BayBiotech.NET The links below provide information on steps CDRH is taking to foster medical device innovation and assure the safety and effectiveness of medical technologies used in the United States. Check out the link below to understand FDA's recommendations for updated Medical Device safety and effectiveness guidelines. CDRH Plan of Action for 510(k) and Science

BayBiotech.NET OECD includes member countries throughout North America, Europe and Asia and has developed guidelines very similar to FDA GLP regulations. OECD regulations are applicable to nonclinical safety studies for pharmaceutical products, animal drugs and food additives, but unlike the FDA GLPs, the OECD regulations are also applicable to studies to evaluate the safety of pesticides and industrial chemicals. Reference: Fundamentals of US Regulatory Affairs, Sixth Edition

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

BayBiotech.NET A good read on Personalized Medicine: http://www.nigms.nih.gov/Initiatives/PGRN/Background/FactSheet.htm

BayBiotech.NET Visit the new FDA page at: www.facebook.com/fda.The page will provide regular updates on FDA news and events as well as Federal health and safety information of interest to the public. Also, FDA is taking its public health message to Flickr. Visit FDA on Flickr at: www.flickr.com/photos/fdaphotos/.

BayBiotech.NET Legal export provisions become applicable only when a device has not been approved or cleared for domestic marketing. Except 21CFR 812.18, no regulations have been codified to establish how the export of unapproved devices must be managed. An unapproved deivce must meet the following criteria in order to qualify the for legal export: 1. meet the foreign purchaser's specifications 2. not be in conflict with the importing country's laws 3. be labeled," intended for export only" on the outside of the shipping package 4. not be sold or offered for sale in domestic commerce Reference: Fundamentals of US Regulatory Affairs, Sixth Edition (Regulatory Affairs Professional Society).

BayBiotech.NET US government has faced challenges in producing medical countermeasures for emerging infectious diseases, pandemics, and bioterrorism that carry the potential for catastrophic impact. President called out the renewed need for a national capability to respond to these threats in the State of the Union, and the Secretary of HHS stepped forward to address this need with new strategies that envision a capabilities-based approach with an active role by the U.S. government in forging partnerships, modernizing regulatory oversight, and supporting transformative technologies. To read about the Medical countermeasure strategies click here .