FDA warns of imposters sending consumers fake warning letters
FDA is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone.
Archive for the ‘Drug Recalls & Safety Notices’ category
Statement by FDA Commissioner Scott Gottlieb, M.D., on formation of a new drug shortages task force and FDA’s efforts to advance long-term solutions to prevent shortages
FDA Commissioner Scott Gottlieb, M.D., on new drug shortages task force and work towards long-term solutions to prevent shortages
FDA expands its support for states to advance implementation of produce safety activities
FDA expands its support for states to advance implementation of produce safety activities
Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies
Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies, including three disease specific draft guidances
Federal judge enters consent decree against Minnesota dairy farm for drug residue violations
Federal judge enters consent decree against Minnesota dairy farm for drug residue violations
FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions
FDA is requiring safety labeling changes for fluoroquinolones to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances.
FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product
FDA granted an EUA to DOD to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma (referred to as French FDP).
Statement by FDA Commissioner Scott Gottlieb, M.D., on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids
FDA Commissioner statement on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem opioid misuse and abuse.
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., on the ongoing risk of salmonella in kratom products
FDA statement on the ongoing risk of salmonella in kratom products
FDA approves novel device for treating breathing difficulty from severe emphysema
FDA approves novel device for treating breathing difficulty from severe emphysema
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online
FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug
Statement from FDA Commissioner Scott Gottlieb, M.D., on developments in the romaine outbreak investigation, recent outbreaks and the use of modern tools to advance food safety
Being able to identify outbreaks is key to being able to take quick action to prevent additional illnesses and find the source of the contamination. In recent years, the FDA and the Centers for Disease Control and Prevention (CDC) have advanced new tools that make it easier and faster to identify outbreaks of human illness […]
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to advance health through improvements in nutrition under the agency’s Nutrition Innovation Strategy
Announcement of public meeting to solicit input on plans to modernize food standards and labeling
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy
FDA approved Epidiolex (cannabidiol) oral solution, the first drug comprised of an active ingredient derived from marijuana, to treat two rare and severe forms of epilepsy.
Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components
FDA Commissioner Scott Gottlieb, M.D., discusses the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components.
FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients
FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients
FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients
FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients
FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes
glucose monitoring system, implantable glucose sensor, adults, diabetes