Istituzioni

FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

Food and Drug Administration - Ve, 24/05/2019 - 06:31
FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder
Categorie: Istituzioni

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

Food and Drug Administration - Gi, 23/05/2019 - 06:16
FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis
Categorie: Istituzioni

FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids

Food and Drug Administration - Gi, 23/05/2019 - 06:16
Agency issued two warning letters to operators of websites that illegally market potentially dangerous, unapproved and misbranded opioid medications.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

Food and Drug Administration - Gi, 23/05/2019 - 06:16
FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.
Categorie: Istituzioni

FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

Food and Drug Administration - Gi, 23/05/2019 - 06:16
FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications
Categorie: Istituzioni

FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines

Food and Drug Administration - Lu, 20/05/2019 - 04:25
FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines - eszopiclone, zaleplon and zolpidem
Categorie: Istituzioni

FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway

Food and Drug Administration - Ve, 17/05/2019 - 02:38
FDA has authorized the marketing of new tobacco products manufactured by Phillip Morris Products S.A. for the IQOS “Tobacco Heating System.”
Categorie: Istituzioni

La FDA exige advertencias más estrictas sobre incidentes poco comunes, pero graves, relacionados con ciertas medicinas recetadas para el insomnio

Food and Drug Administration - Ve, 03/05/2019 - 20:07
La FDA exige advertencias más estrictas sobre incidentes poco comunes, pero graves, relacionados con ciertas medicinas recetadas para el insomnio: eszopiclona, zaleplón y zolpidem.
Categorie: Istituzioni

FDA approves first treatment for all genotypes of hepatitis C in pediatric patients

Food and Drug Administration - Ve, 03/05/2019 - 20:07
FDA approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17.
Categorie: Istituzioni

FDA statement on approval of OTC Primatene Mist to treat mild asthma

Food and Drug Administration - Ve, 03/05/2019 - 20:07
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

FDA statement on FDA’s modern approach to advanced pharmaceutical manufacturing

Food and Drug Administration - Ve, 03/05/2019 - 20:07
FDA issues information to industry on advanced pharmaceutical manufacturing
Categorie: Istituzioni

La FDA emprende una campaña de educación ciudadana para instar a la eliminación segura de los analgésicos opiáceos sin usar del hogar

Food and Drug Administration - Ve, 03/05/2019 - 20:07
La campaña “Elimine el Riesgo“ va dirigida a mujeres de entre 35 y 64 años de edad, quienes son las más proclives a participar en las decisiones de salud en el hogar, y con frecuencia son las que controlan el acceso de los opioides y otros medicamentos de prescripción médica en el hogar.
Categorie: Istituzioni

FDA approves device to help increase access to more lungs for transplant

Food and Drug Administration - Ve, 03/05/2019 - 20:07
The device enables doctors to better assess lungs that were initially deemed to be unsuitable for transplant
Categorie: Istituzioni

FDA approves first treatment for pediatric patients with lupus

Food and Drug Administration - Ve, 03/05/2019 - 20:07
FDA approves Benlysta for treatment of children with systemic lupus erythematosus (SLE), a chronic disease causing inflammation and damage to tissue and organs
Categorie: Istituzioni

FDA approves first treatment for rare blood disease

Food and Drug Administration - Ve, 03/05/2019 - 20:07
The FDA approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.
Categorie: Istituzioni

Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data

Food and Drug Administration - Ve, 03/05/2019 - 20:07
FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.
Categorie: Istituzioni

FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

Food and Drug Administration - Ve, 03/05/2019 - 20:07
The FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur development of drugs targeting serious infections in limited patient populations with unmet need.
Categorie: Istituzioni

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

Food and Drug Administration - Ve, 03/05/2019 - 20:07
FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.
Categorie: Istituzioni

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

Food and Drug Administration - Ve, 03/05/2019 - 20:07
“Remove the Risk” to raise awareness about proper disposal of prescription opioids
Categorie: Istituzioni
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