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FDA

Food and Drug Administration

  • Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

    FDA announces new draft guidance titled, Competitive Generic Therapies, to help provide even greater clarity to industry about the CGT pathway.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631456.htm
    Fri, 15 Feb 2019 10:00:00 -0500
  • FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

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

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631412.htm
    Thu, 14 Feb 2019 15:29:00 -0500
  • FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants

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

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631390.htm
    Thu, 14 Feb 2019 12:43:00 -0500
  • 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. 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

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631290.htm
    Wed, 13 Feb 2019 11:20:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs

    FDA announces programs to promote adoption of innovations in drug manufacturing

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631293.htm
    Wed, 13 Feb 2019 10:43:00 -0500
  • 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

    FDA issues first warning letter under Drug Supply Chain Security Act to McKesson Corp. for violations highlighted by a concerning tampering incident.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631195.htm
    Tue, 12 Feb 2019 09:51:00 -0500
  • 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

    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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631112.htm
    Mon, 11 Feb 2019 13:39:00 -0500
  • 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

    FDA announces new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631065.htm
    Mon, 11 Feb 2019 09:26:00 -0500
  • FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

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

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631064.htm
    Mon, 11 Feb 2019 09:29:00 -0500
  • 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

    FDA announces pilot program to improve ability to trace prescription drugs at all points in the drug distribution chain.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630942.htm
    Thu, 07 Feb 2019 16:31:00 -0500
  • FDA pursues order barring specific retailers from selling tobacco products as part of its continuing efforts to target youth tobacco use

    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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630913.htm
    Thu, 07 Feb 2019 10:47:00 -0500
  • 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 FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630906.htm
    Thu, 07 Feb 2019 09:36:00 -0500
  • 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

    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

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630895.htm
    Wed, 06 Feb 2019 17:54:00 -0500
  • Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions

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

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630883.htm
    Wed, 06 Feb 2019 15:35:00 -0500
  • FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder

    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.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630851.htm
    Wed, 06 Feb 2019 11:38:00 -0500
  • 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.

    Medical product distributor issued voluntary recall of certain Roche Diagnostics test strips used with CoaguChek test meter devices.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630408.htm
    Fri, 01 Feb 2019 13:17:00 -0500
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on 2019 efforts to advance the development of complex generics to improve patient access to medicines

    FDA Commissioner on 2019 efforts to advance the development of complex generics to improve patient access to medicines

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630160.htm
    Wed, 30 Jan 2019 16:01:00 -0500
  • FDA approves first generic Advair Diskus

    FDA approved the first generic of Advair Diskus for treatment of asthma and maintenance treatment of airflow obstruction and reducing exacerbations with COPD.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630151.htm
    Wed, 30 Jan 2019 15:49:00 -0500
  • 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

    FDA announces new policies to ensure the Orange Book provides the greatest benefit to patients and providers, and generic drug developers.

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630098.htm
    Wed, 30 Jan 2019 11:50:00 -0500
  • 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

    Review of 2018 device innovations, with record-setting 106 novel device approvals, and new actions FDA is taking to modernize approach to safety

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm629917.htm
    Mon, 28 Jan 2019 13:26:00 -0500

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