Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s).  The approval of […]

Background The National Institute of Diabetes and Digestive and Kidney Diseases reports that almost 5% of the U.S. population above the age of 12 years have […]

Background Computational modeling and simulation (M&S) have been recognized as powerful tools in facilitating drug and medical device development and regulatory research, with the capability to […]

Background Nitrosamines are a class of chemicals that commonly occur as impurities in water, beverages, and foods (particularly in cured and grilled meats). Although nitrosamines are […]

On This Page Date: October 4 – 6, 2021 Organized By: GSRS21 – Virtual Conference Title:         11th Annual Global Summit on Regulatory Science (GSRS21)        […]

Image Español If you’re taking a medication, is it safe to drive? Most likely, yes. Still, before driving or operating other heavy machinery, the U.S. Food […]

Product: Drugs Recipient: Recipient Name Eric C. Ritter Spirochaete Research Labs, LLC aka Scitus Laboratory Products 822 Terry Rd.Hauppauge, NY 11788United States [email protected] Issuing Office: Center […]