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
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
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 granted an EUA to DOD to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma (referred to as French FDP).
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.
FDA statement on the ongoing risk of salmonella in kratom products
FDA approves novel device for treating breathing difficulty from severe emphysema
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
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 […]
Announcement of public meeting to solicit input on plans to modernize food standards and labeling
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.
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 approves automated insulin delivery and monitoring system for use in younger pediatric patients
glucose monitoring system, implantable glucose sensor, adults, diabetes
Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products