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Press releases from FDA
Updated: 1 hour 41 min ago

Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs

Tue, 2018-07-17 08:16
FDA describes innovative approaches to increase access to a broader selection of nonprescription drug products for consumers

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

Fri, 2018-07-13 16:35
FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure

FDA approves the first drug with an indication for treatment of smallpox

Fri, 2018-07-13 14:09
FDA today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox.

FDA warns of imposters sending consumers fake warning letters

Fri, 2018-07-13 09:25
FDA is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone.

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

Thu, 2018-07-12 12:12
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

Thu, 2018-07-12 09:46
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

Wed, 2018-07-11 09:23
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

Tue, 2018-07-10 14:40
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

Tue, 2018-07-10 14:28
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

Tue, 2018-07-10 08:52
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

Mon, 2018-07-09 09:46
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 approves novel device for treating breathing difficulty from severe emphysema

Fri, 2018-06-29 12:03
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

Thu, 2018-06-28 16:23
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

Thu, 2018-06-28 15:53
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

Thu, 2018-06-28 15:17
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 and to link them back to the food source that is the culprit responsible for the illnesses. But our improved ability to spot outbreaks has also caused some to question whether we are experiencing more foodborne outbreaks now than in the past.

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

Tue, 2018-06-26 10:15
Announcement of public meeting to solicit input on plans to modernize food standards and labeling

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

Mon, 2018-06-25 11:36
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 approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

Mon, 2018-06-25 11:36
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 permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

Fri, 2018-06-22 11:55
FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

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