FDA and NRC today took important steps to ensure a stable and secure supply of a critical radioactive imaging product used to detect potentially life-threatening diseases
FDA statement on scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse
One part of the Food and Drug Administration’s mission is to ensure the safety of electronic products that emit radiation, like televisions and cell phones. These types of products are part of Americans’ daily life and we take our duty to protect consumers with the utmost gravity. With cell phones, we have relied extensively on […]
FDA provides update on ongoing efforts to mitigate impact of saline shortages and monitor other critical products during flu season
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
FDA Commissioner Dr. Scott Gottlieb and USDA Secretary Perdue launched an effort today to increase collaboration, efficiency and effectiveness, and provide clarity to food producers.
FDA approves first radioactive drug for a certain type of digestive tract cancer called GEP-NETs
FDA strengthens commitments to humane and judicious animal research and the termination of a nicotine study
FDA and FTC issued joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal
FDA discusses new policy steps for strengthening public warning and notification of recalls
Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA — that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish […]
FDA updates on some ongoing shortages related to IV fluids
The U.S. Food and Drug Administration and the Department of Defense launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.
FDA takes steps to enhance transparency of clinical trial data used in support of new drug approvals
: FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
FDA approves first treatment for breast cancer with a certain inherited genetic mutation
FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
The U.S. Food and Drug Administration announced today that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes […]