Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes

Food and Drug Administration - Gi, 21/02/2019 - 16:07
FDA releases the second of two draft guidances aimed at supporting the development of novel nicotine replacement therapies.
Categorie: Istituzioni

FDA advances new proposed regulation to make sure that sunscreens are safe and effective

Food and Drug Administration - Gi, 21/02/2019 - 15:01
FDA issues a proposed rule that would update regulatory requirements for most sunscreen products in the United States
Categorie: Istituzioni

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

Food and Drug Administration - Ve, 15/02/2019 - 16:00
FDA announces new draft guidance titled, Competitive Generic Therapies, to help provide even greater clarity to industry about the CGT pathway.
Categorie: Istituzioni

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

Food and Drug Administration - Gi, 14/02/2019 - 21:29
FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices
Categorie: Istituzioni

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

Food and Drug Administration - Gi, 14/02/2019 - 18:43
FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants
Categorie: Istituzioni

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

Food and Drug Administration - Me, 13/02/2019 - 17:20
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
Categorie: Istituzioni

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

Food and Drug Administration - Ma, 12/02/2019 - 15:51
FDA issues first warning letter under Drug Supply Chain Security Act to McKesson Corp. for violations highlighted by a concerning tampering incident.
Categorie: Istituzioni

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

Food and Drug Administration - Lu, 11/02/2019 - 19:39
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.
Categorie: Istituzioni

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

Food and Drug Administration - Lu, 11/02/2019 - 15:29
FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease
Categorie: Istituzioni

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

Food and Drug Administration - Lu, 11/02/2019 - 15:26
FDA announces new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight
Categorie: Istituzioni

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

Food and Drug Administration - Gi, 07/02/2019 - 22:31
FDA announces pilot program to improve ability to trace prescription drugs at all points in the drug distribution chain.
Categorie: Istituzioni

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

Food and Drug Administration - Gi, 07/02/2019 - 16:47
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.
Categorie: Istituzioni

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

Food and Drug Administration - Gi, 07/02/2019 - 15:36
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
Categorie: Istituzioni

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

Food and Drug Administration - Me, 06/02/2019 - 23:54
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
Categorie: Istituzioni

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

Food and Drug Administration - Me, 06/02/2019 - 21:35
Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions
Categorie: Istituzioni

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

Food and Drug Administration - Me, 06/02/2019 - 17:38
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.
Categorie: Istituzioni

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.

Food and Drug Administration - Ve, 01/02/2019 - 19:17
Medical product distributor issued voluntary recall of certain Roche Diagnostics test strips used with CoaguChek test meter devices.
Categorie: Istituzioni

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

Food and Drug Administration - Me, 30/01/2019 - 22:01
FDA Commissioner on 2019 efforts to advance the development of complex generics to improve patient access to medicines
Categorie: Istituzioni
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