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 - Ma, 13/11/2018 - 16:06
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

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

Food and Drug Administration - Ve, 09/11/2018 - 21:51
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 authorizes emergency use of first Ebola fingerstick test with portable reader

Food and Drug Administration - Ve, 09/11/2018 - 16:22
FDA authorizes emergency use of first Ebola fingerstick test with portable reader
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

Food and Drug Administration - Gi, 08/11/2018 - 18:08
The FDA is committed to the expanded access program which provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases and life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma

Food and Drug Administration - Gi, 08/11/2018 - 15:18
FDA approves new version of OTC Primatene Mist inhaler to treat mild, intermittent asthma for people who have been diagnosed with asthma by their physician
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market

Food and Drug Administration - Lu, 05/11/2018 - 17:10
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market
Categorie: Istituzioni

FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

Food and Drug Administration - Ve, 02/11/2018 - 19:52
FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery
Categorie: Istituzioni

FDA and DoD formalize collaboration to advance medical products in support of American military personnel

Food and Drug Administration - Ve, 02/11/2018 - 18:45
FDA and DoD formalize collaboration to advance medical products in support of American military personnel. New Memorandum of Understanding aligns agency efforts to foster the development and use of safe and effective medical products for members of the U.S. military.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids

Food and Drug Administration - Ve, 02/11/2018 - 18:29
FDA announces approval of Dsuvia and new steps the agency may be taking to evaluate opioids.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation

Food and Drug Administration - Ve, 02/11/2018 - 14:46
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation
Categorie: Istituzioni

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

Food and Drug Administration - Gi, 01/11/2018 - 21:53
Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks

Food and Drug Administration - Gi, 01/11/2018 - 19:24
Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks
Categorie: Istituzioni

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health on the National Toxicology Program’s report on radiofrequency energy exposure

Food and Drug Administration - Gi, 01/11/2018 - 15:30
Statement from Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on the recent National Toxicology Program report release on radiofrequency energy exposure
Categorie: Istituzioni

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

Food and Drug Administration - Me, 31/10/2018 - 21:37
FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
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, 31/10/2018 - 14:09
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 takes action to stop the use of lead acetate in hair dyes

Food and Drug Administration - Ma, 30/10/2018 - 16:10
FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.
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 - Ma, 30/10/2018 - 15:16
FDA announces new plan to advance the development of plant and animal biotechnology innovation
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food and Drug Administration - Lu, 29/10/2018 - 14:15
Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.
Categorie: Istituzioni
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