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News & Events

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

Tue, 2019-04-30 19:19
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.

FDA Statement on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue

Tue, 2019-04-30 19:19
FDA announces list of nitrosamine-free ARB medications confirmed by the agency to help patients and healthcare providers

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

Fri, 2019-04-26 21:31
The device enables doctors to better assess lungs that were initially deemed to be unsuitable for transplant

FDA approves first treatment for pediatric patients with lupus

Fri, 2019-04-26 21:31
FDA approves Benlysta for treatment of children with systemic lupus erythematosus (SLE), a chronic disease causing inflammation and damage to tissue and organs

FDA approves first treatment for rare blood disease

Fri, 2019-04-26 21:31
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.

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

Fri, 2019-04-26 21:31
FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.

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

Fri, 2019-04-26 21:31
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.

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

Fri, 2019-04-26 21:31
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

La FDA aprueba nuevo medicamento para tratar la influenza

Fri, 2019-04-26 21:31
La FDA aprueba nuevo medicamento para tratar la influenza

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

Fri, 2019-04-26 21:31
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.

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

Fri, 2019-04-26 21:31
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

FDA approves new drug to treat travelers’ diarrhea

Fri, 2019-04-26 21:31
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.

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

Fri, 2019-04-26 21:31
FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.

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

Fri, 2019-04-26 21:31
“Remove the Risk” to raise awareness about proper disposal of prescription opioids

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

Fri, 2019-04-26 21:31
FDA announces new plan to advance the development of plant and animal biotechnology innovation

FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan

Fri, 2019-04-26 21:31
FDA issued a warning letter to Electric Lotus LLC for selling nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products.

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness...

Fri, 2019-04-26 21:31
FDA provides updates on two elements in medical device safety action plan: modernizing 510(k) program and new process for establishing special controls.

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

Fri, 2019-04-26 21:31
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

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

Fri, 2019-04-26 21:31
FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics

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

Fri, 2019-04-26 21:31
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

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