Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA efforts to support more efficient development of targeted therapies

Food and Drug Administration - Me, 21/08/2019 - 02:12
FDA issues two draft guidances that will provide medical product developers with greater clarity on the FDA’s recommendations for researching and developing the next generation of individualized therapies.
Categorie: Istituzioni

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical In

Food and Drug Administration - Ma, 20/08/2019 - 01:13
FDA Commissioner Gottlieb testifies before the U.S. Senate Committee on Health, Education, Labor & Pensions on the agency’s implementation of the 21st Century Cures Act
Categorie: Istituzioni

FDA warns consumers about the dangerous and potentially life threating side effects of Miracle Mineral Solution

Food and Drug Administration - Lu, 19/08/2019 - 00:36
The FDA is warning consumers not to purchase or drink Miracle Mineral Solution, a product sold online as a medical treatment due to a recent rise in reported health issues.
Categorie: Istituzioni

Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development

Food and Drug Administration - Lu, 19/08/2019 - 00:36
FDA issues statement on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development
Categorie: Istituzioni

FDA clears new indications for existing Lyme disease tests that may help streamline diagnoses

Food and Drug Administration - Sa, 17/08/2019 - 23:48
FDA clears new indications for existing Lyme disease tests that may help streamline diagnoses
Categorie: Istituzioni

FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market

Food and Drug Administration - Ve, 16/08/2019 - 23:11
FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market
Categorie: Istituzioni

FDA approves first treatment for severe hypoglycemia that can be administered without an injection

Food and Drug Administration - Gi, 15/08/2019 - 22:56
FDA approves Baqsimi nasal powder, the first glucagon therapy for the emergency treatment of severe hypoglycemia that can be administered without an injection.
Categorie: Istituzioni

FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety

Food and Drug Administration - Gi, 15/08/2019 - 22:56
FDA has issued a warning letter to Curaleaf Inc. for illegally selling unapproved cannabidiol products online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.
Categorie: Istituzioni

FDA suspends facility registration of Texas-based seafood producer after significant, repeated food safety violations

Food and Drug Administration - Me, 14/08/2019 - 22:27
FDA suspends facility registration of Texas-based seafood producer
Categorie: Istituzioni

FDA approves first generics of Lyrica

Food and Drug Administration - Me, 14/08/2019 - 22:27
FDA approves first generics of Lyrica (pregabalin)
Categorie: Istituzioni

FDA launches its first youth e-cigarette prevention TV ads, plans new educational resources as agency approaches one-year anniversary of public education campaign

Food and Drug Administration - Me, 14/08/2019 - 22:27
FDA is launching its first youth e-cigarette prevention TV ads and is planning to provide new educational resources as agency approaches one-year anniversary of public education campaign.
Categorie: Istituzioni

Federal judge enters consent decree against Arkansas food and medical product grocery warehouse for insanitary conditions

Food and Drug Administration - Do, 11/08/2019 - 20:55
A federal court ordered an Arkansas company to stop distributing food, drug products, medical devices and cosmetics until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.
Categorie: Istituzioni

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

Food and Drug Administration - Ve, 09/08/2019 - 19:56
“Remove the Risk” to raise awareness about proper disposal of prescription opioids
Categorie: Istituzioni

FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections

Food and Drug Administration - Me, 07/08/2019 - 19:22
FDA approved Recarbrio, an antibacterial drug to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
Categorie: Istituzioni

Statement on the agency’s actions to tackle the epidemic of youth vaping and court ruling on application submission deadlines for certain tobacco products, including e-cigarettes

Food and Drug Administration - Ma, 06/08/2019 - 19:02
FDA issues statement on actions to tackle youth vaping epidemic and court ruling on application deadlines for certain tobacco products, including e-cigarettes
Categorie: Istituzioni

FDA approves new treatment for refractory multiple myeloma

Food and Drug Administration - Sa, 03/08/2019 - 17:58
FDA grants accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other form
Categorie: Istituzioni

FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk with significant violations of manufacturing quality standards

Food and Drug Administration - Ve, 02/08/2019 - 17:21
FDA has issued warning letters to three repackers of active pharmaceutical ingredients (API) for significant violations of current good manufacturing practice (CGMP) requirements
Categorie: Istituzioni

Statement on steps to make health care professional and patient labeling information for prescription medications consistent and clear

Food and Drug Administration - Ve, 02/08/2019 - 17:21
FDA is issuing two new draft guidances on drug labeling, Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products - Content and Format and Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic
Categorie: Istituzioni

FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps

Food and Drug Administration - Ve, 02/08/2019 - 17:21
FDA warns patients and providers that certain Medtronic MiniMed insulin pumps are recalled due to potential cybersecurity risks and recommends patients switch to models better equipped to protect against these potential risks.
Categorie: Istituzioni
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