Clinical Operations-Design to Execution

FDA Adverse Events Reporting System (FAERS) Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) BayBiotech.NET

Press Announcements FDA to approve shared system REMS for TIRF products BayBiotech.NET

Consumer Updates Nov. 30 Webinar: How FDA Regulates Imported Products BayBiotech.NET

CDRH Strategic Planning CDRH 2011 Strategic Priorities BayBiotech.NET

Consumer Updates A Glimpse at 'Gluten-Free' Food Labeling BayBiotech.NET

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