FDA Begins Real-Time Reporting of Adverse Event Data
The U.S. Food and Drug Administration (FDA) today began publishing adverse event data on a daily basis, giving the public faster access to information on serious medication errors and product…
HHS Allows FDA Emergency Use of Animal Drugs to Combat New World Screwworm, Protect U.S. Food Supply
The U.S. Department of Health and Human Services (HHS) today issued a declaration that allows the U.S. Food and Drug Administration (FDA) to issue Emergency Use Authorizations (EUAs) for animal…
FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis
FDA approved Papzimeos, the first-of-its-kind non-replicating adenoviral vector-based immunotherapy for use in adults with recurrent respiratory papillomatosis. Source: FDA Press Releases
Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products
Statement from FDA Commissioner Marty Makary, M.D., M.P.H., on Florida Restriction of 7-OH Opioid Products Source: FDA Press Releases
FDA Commissioner Makary, USDA Secretary Rollins Celebrate Proposed Modernization of Orange Juice Regulations to Benefit American Growers
U.S. FDA Commissioner Dr. Marty Makary, M.D., M.P.H., and U.S. Secretary of Agriculture Brooke L. Rollins this week announced plans to support American citrus growers and cut bureaucratic barriers by…
A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: Announcing Resolution of the IV Saline Solutions Shortage
A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: Announcing Resolution of the IV Saline Solutions Shortage Source: FDA Press Releases
FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing
The U.S. Food and Drug Administration today announced FDA PreCheck, a new program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing…
FDA Names Top HHS Lawyer as Chief Counsel
The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced that Sean Keveney has been appointed Chief Counsel at the FDA. Source:…
FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks
FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks Source: FDA Press Releases
FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers
FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers Source: FDA Press Releases