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Press releases from FDA
Updated: 1 hour 26 min ago

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

Thu, 2019-02-14 14:29
FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants

Thu, 2019-02-14 11:43
FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas on findings from the agency’s investigation of the November 2018 outbreak of <em>E. coli</em> O157:H7 in California-linked romaine lettuce

Wed, 2019-02-13 10:20
Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas on findings from the agency’s investigation of the November 2018 outbreak of E. coli O157:H7 in California-linked romaine lettuce

Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic

Tue, 2019-02-12 08:51
FDA issues first warning letter under Drug Supply Chain Security Act to McKesson Corp. for violations highlighted by a concerning tampering incident.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use

Mon, 2019-02-11 12:39
Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use.

FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

Mon, 2019-02-11 08:29
FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

Mon, 2019-02-11 08:26
FDA announces new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

FDA takes new steps to adopt more modern technologies for improving the security of the drug supply chain through innovations that improve tracking and tracing of medicines

Thu, 2019-02-07 15:31
FDA announces pilot program to improve ability to trace prescription drugs at all points in the drug distribution chain.

FDA pursues order barring specific retailers from selling tobacco products as part of its continuing efforts to target youth tobacco use

Thu, 2019-02-07 09:47
FDA has initiated enforcement action against certain retail locations of Walgreen Co. and Circle K Stores Inc. for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls

Thu, 2019-02-07 08:36
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants

Wed, 2019-02-06 16:54
Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants

Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions

Wed, 2019-02-06 14:35
Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions

FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder

Wed, 2019-02-06 10:38
FDA approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting.

FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.

Fri, 2019-02-01 12:17
Medical product distributor issued voluntary recall of certain Roche Diagnostics test strips used with CoaguChek test meter devices.

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2019 efforts to advance the development of complex generics to improve patient access to medicines

Wed, 2019-01-30 15:01
FDA Commissioner on 2019 efforts to advance the development of complex generics to improve patient access to medicines

FDA approves first generic Advair Diskus

Wed, 2019-01-30 14:49
FDA approved the first generic of Advair Diskus for treatment of asthma and maintenance treatment of airflow obstruction and reducing exacerbations with COPD.

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to enhance the utility of the Orange Book to foster drug competition

Wed, 2019-01-30 10:50
FDA announces new policies to ensure the Orange Book provides the greatest benefit to patients and providers, and generic drug developers.

Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on a record year for device innovation

Mon, 2019-01-28 12:26
Review of 2018 device innovations, with record-setting 106 novel device approvals, and new actions FDA is taking to modernize approach to safety

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