Archive for the ‘Food Safety News’ 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

July 12, 2018

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

July 12, 2018

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

July 11, 2018

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

July 10, 2018

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

July 10, 2018

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

July 10, 2018

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

July 9, 2018

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

July 2, 2018

FDA statement on the ongoing risk of salmonella in kratom products

FDA approves novel device for treating breathing difficulty from severe emphysema

June 29, 2018

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

June 28, 2018

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

June 28, 2018

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

June 28, 2018

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

June 26, 2018

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

June 25, 2018

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

June 25, 2018

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

June 22, 2018

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

June 21, 2018

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

June 21, 2018

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

June 19, 2018

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

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