FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall
FDA provides update on ongoing investigation into ARB drugs; new losartan recall announced (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA ’s Youth Tobacco Prevention Plan
. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
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
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
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
FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
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
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 (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency ’s ongoing Youth Tobacco Prevention Plan
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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
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 of medical devices
FDA provides updates on two elements in medical device safety action plan: modernizing 510(k) program and new process for establishing special controls. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
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
FDA announces new plan to advance the development of plant and animal biotechnology innovation (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes
“Remove the Risk” to raise awareness about proper disposal of prescription opioids (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications
FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
FDA approves new drug to treat travelers ’ diarrhea
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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse
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 (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
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
. (Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
La FDA autoriza la primera prueba de comercializaci ón directa al consumidor para la detección de variantes genéticas que pudieran estar relacionadas con la metabolización farmacológica
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
La FDA aprueba nuevo medicamento para tratar la influenza
(Source: Food and Drug Administration)
Source: Food and Drug Administration - April 27, 2019 Category: American Health Authors: FDA Source Type: news
