Istituzioni

Statement by FDA Commissioner Scott Gottlieb, M.D., on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids

Food and Drug Administration - Lu, 09/07/2018 - 16:46
FDA Commissioner statement on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem opioid misuse and abuse.
Categorie: Istituzioni

FDA approves novel device for treating breathing difficulty from severe emphysema

Food and Drug Administration - Ve, 29/06/2018 - 19:03
FDA approves novel device for treating breathing difficulty from severe emphysema
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online

Food and Drug Administration - Gi, 28/06/2018 - 23:23
FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Food and Drug Administration - Gi, 28/06/2018 - 22:53
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on developments in the romaine outbreak investigation, recent outbreaks and the use of modern tools to advance food safety

Food and Drug Administration - Gi, 28/06/2018 - 22:17
Being able to identify outbreaks is key to being able to take quick action to prevent additional illnesses and find the source of the contamination. In recent years, the FDA and the Centers for Disease Control and Prevention (CDC) have advanced new tools that make it easier and faster to identify outbreaks of human illness and to link them back to the food source that is the culprit responsible for the illnesses. But our improved ability to spot outbreaks has also caused some to question whether we are experiencing more foodborne outbreaks now than in the past.
Categorie: Istituzioni

Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components

Food and Drug Administration - Lu, 25/06/2018 - 18:36
FDA Commissioner Scott Gottlieb, M.D., discusses the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components.
Categorie: Istituzioni

FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

Food and Drug Administration - Lu, 25/06/2018 - 18:36
FDA approved Epidiolex (cannabidiol) oral solution, the first drug comprised of an active ingredient derived from marijuana, to treat two rare and severe forms of epilepsy.
Categorie: Istituzioni

FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

Food and Drug Administration - Ve, 22/06/2018 - 18:55
FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients
Categorie: Istituzioni

FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients

Food and Drug Administration - Gi, 21/06/2018 - 23:10
FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients
Categorie: Istituzioni

Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products

Food and Drug Administration - Ma, 19/06/2018 - 21:03
Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply

Food and Drug Administration - Ma, 19/06/2018 - 16:27
FDA releases draft guidance to help food manufacturers implement the Intentional Adulteration rule under the FDA Food Safety Modernization Act
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products

Food and Drug Administration - Ve, 15/06/2018 - 16:04
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products
Categorie: Istituzioni

FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence

Food and Drug Administration - Gi, 14/06/2018 - 22:49
: FDA approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food

Food and Drug Administration - Gi, 14/06/2018 - 15:26
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making

Food and Drug Administration - Ma, 12/06/2018 - 16:44
FDA issues draft guidance on collecting patient experiences to inform the development and evaluation of medical products
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections

Food and Drug Administration - Ma, 12/06/2018 - 16:20
The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. FDA is taking steps to combat antibiotic-resistant bacteria.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

Food and Drug Administration - Ma, 12/06/2018 - 15:33
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care
Categorie: Istituzioni
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