Istituzioni

La FDA aprueba nuevo medicamento para tratar la influenza

Food and Drug Administration - Me, 01/05/2019 - 19:00
La FDA aprueba nuevo medicamento para tratar la influenza
Categorie: Istituzioni

La FDA autoriza la primera prueba de comercialización directa al consumidor para la detección de variantes genéticas que pudieran estar relacionadas con la metabolización farmacológica

Food and Drug Administration - Me, 01/05/2019 - 19:00
La FDA autoriza la primera prueba de comercialización directa al consumidor para la detección de variantes genéticas que pudieran estar relacionadas con la metabolización farmacológica
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use

Food and Drug Administration - Me, 01/05/2019 - 19:00
Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use.
Categorie: Istituzioni

FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse

Food and Drug Administration - Me, 01/05/2019 - 19:00
U.S. Marshals Service has conducted a mass seizure of FDA-regulated products that were being held in an Arkansas grocery warehouse under insanitary conditions
Categorie: Istituzioni

FDA approves new drug to treat travelers’ diarrhea

Food and Drug Administration - Sa, 27/04/2019 - 17:25
FDA approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on the FDA’s new plan to advance plant, animal biotechnology innovation

Food and Drug Administration - Sa, 27/04/2019 - 17:25
FDA announces new plan to advance the development of plant and animal biotechnology innovation
Categorie: Istituzioni

FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act

Food and Drug Administration - Sa, 27/04/2019 - 17:25
FDA’s Anna Abram’s testimony for U.S. House Committee on Energy and Commerce Subcommittee on Health on the Pandemic and All-Hazards Preparedness Act
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics

Food and Drug Administration - Sa, 27/04/2019 - 17:25
FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics
Categorie: Istituzioni

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

Food and Drug Administration - Sa, 27/04/2019 - 17:25
FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan

Food and Drug Administration - Sa, 27/04/2019 - 17:25
Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan.
Categorie: Istituzioni

FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes

Food and Drug Administration - Gi, 25/04/2019 - 16:33
“Remove the Risk” to raise awareness about proper disposal of prescription opioids
Categorie: Istituzioni

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples

Food and Drug Administration - Ma, 23/04/2019 - 16:41
Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples
Categorie: Istituzioni

Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine

Food and Drug Administration - Lu, 22/04/2019 - 18:29
The FDA wants to underscore our continued confidence in the safety and effectiveness of the vaccines that are highly successful at preventing – in some cases, nearly eradicating – preventable diseases. Large well-designed studies have confirmed the safety and effectiveness of the MMR vaccine and have demonstrated that administration of the vaccine is not associated with the development of autism. MMR vaccine has been approved in the United States for nearly 50 years to prevent measles, mumps and rubella (also known as German Measles). As a result of its use, measles and rubella were completely eradicated in the United States, and mumps cases decreased by 99%.
Categorie: Istituzioni

FDA permits marketing of first medical device for treatment of ADHD

Food and Drug Administration - Sa, 20/04/2019 - 00:08
FDA permits marketing of first medical device for treatment of ADHD
Categorie: Istituzioni

FDA approves first generic naloxone nasal spray to treat opioid overdose

Food and Drug Administration - Ve, 19/04/2019 - 17:20
FDA granted approval of the 1st generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose
Categorie: Istituzioni

FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements

Food and Drug Administration - Ma, 16/04/2019 - 18:42
FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements
Categorie: Istituzioni
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