FDA Research Focused on Direct-to-Consumer Television Advertising Clinical endpoints are measurable events or outcomes that can help determine whether a medical intervention, such as a therapy, […]

A biosimilar product (biosimilar) is highly similar to, and has no clinically meaningful differences from, an FDA-approved reference product. Biosimilars may spur competition and result in […]

CDER investigates the utility of a text messaging app to obtain patient-reported information that can help FDA improve opioid prescription guidelines for surgical patients. The Public […]

Contributed by Shetarra Walker, MD, MSCR, Lead Physician and Clinical Team Leader, Office of Rare Disease, Pediatrics, Urologic and Reproductive Medicine, CDER, and Salim F. Idriss, […]

Ranitidine, which blocks histamine-induced acid secretion in the stomach, was approved in 1983. It became widely used over the ensuing decades as a prescription and over-the-counter […]

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 […]