Search Results for CDC

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New Study Says 63% of US Adults Trust FDA By Zachary Brennan - Published 17 May 2017

A study published Tuesday in PLOS reveals that the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) might have more work to do to ensure Americans trust them.

Categories: News, US, FDA, Business and Leadership, Communication, Drugs, Government affairs

Tags: FDA public opinion, CDC

FDA, CDC Find Contaminated Water at Florida Plant Linked to Multistate Outbreak By Zachary Brennan - Published 12 October 2016

An investigation into a multistate outbreak has identified the bacteria, Burkholderia cepacia, in more than 10 lots of oral liquid docusate sodium linked directly to a contract manufacturing organization’s (CMO) Florida-based site.

Categories: News, US, FDA, Business and Leadership, Compliance, Crisis management, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: bacterial outbreak, CDC, PharmaTech, US drug manufacturing

Genetically Engineered Mosquitoes to Aid Zika Response? FDA Plans to Release More Info By Michael Mezher - Published 02 March 2016

The US Food and Drug Administration's (FDA) acting chief scientist told members of the House Energy and Commerce Committee on Wednesday that FDA is investigating all avenues to combat Zika, including a proposal to release genetically engineered mosquitoes in Florida.

Categories: News, Latin America and Caribbean, US, Anvisa, FDA, Biologics and biotechnology, In vitro diagnostics

Tags: Zika, Zika virus, MAC-ELISA, CDC, NIAID, Oxitec

FDA Clears First Zika Diagnostic for Emergency Use By Michael Mezher - Published 26 February 2016

The US Food and Drug Administration (FDA) on Friday approved the first diagnostic to detect the Zika virus under its emergency use authorization (EUA) pathway, which allows the agency to authorize unapproved products during a public health emergency.

Categories: News, Latin America and Caribbean, US, FDA, In vitro diagnostics

Tags: Zika, Zika diagnostic, Zika test, Zika MAC-ELISA, Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay, CDC

CDC, NIH 'Working Closely' With FDA on Zika Response By Michael Mezher - Published 10 February 2016

At a Congressional hearing in Washington, DC on Wednesday, officials from the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) say they are working closely with the US Food and Drug Administration (FDA) in their response to the Zika virus.

Categories: News, Latin America and Caribbean, US, FDA, Biologics and biotechnology, Communication, Government affairs, Submission and registration

Tags: Zika virus, Accelerated approval, CDC, NIH, Anthony Fauci, Tom Frieden

African Union, WHO Team Up to Launch African CDC By Michael Mezher - Published 12 May 2015

Officials at the African Union Commission (AUC) and the World Health Organization Regional Office for Africa (WHO/AFRO) are looking to address the shortcomings of the international response to the Ebola crisis by launching a new disease monitoring agency, the Centres for Disease Control and Prevention in Africa (African CDC).

Categories: News, Africa

Tags: African CDC, WHO, African Union Commission, AUC

FDA, CDC Preparing Updated Form to Record Vaccination Problems By Alexander Gaffney, RAC - Published 24 November 2014

The US Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) are calling for comments on a new adverse event reporting form for vaccines meant to replace the current paper-based reporting form.

Categories: News, US, CBER, Biologics and biotechnology, Postmarket surveillance

Tags: VAERS, VAERS 1.0, VAERS 2.0, Vaccine Adverse Event Reporting System, CDC, Centers for Disease Control and Prevention, Vaccine

FDA Review Finds Storage Problems at Food, Supplement Regulator CFSAN By Alexander Gaffney, RAC - Published 09 September 2014

The US Food and Drug Administration (FDA) has announced that it has found still more vials of improperly stored hazardous substances in one of its labs, just weeks after the agency announced that it had found dozens of other vials of hazardous substances, including the smallpox virus.

Categories: News, US, FDA, Audit, Nutritional and dietary supplements

Tags: CFSAN, Staphylococcus enterotoxin, SE, Select Agent Program, CDC

FDA Again Leverages Emergency Use Authority, Seeking to Stay Ahead of Deadly Mystery Virus By Alexander Gaffney, RF News Editor - Published 07 June 2013

Categories: US, FDA

Tags: Emergency Use Authorization, CDC, EUA, Emergency, Latest News, DHHS, virus, medical device

FDA, Others Plan Meeting to Address Antimicrobial Resistance By Alexander Gaffney - Published 19 September 2012

Categories: FDA

Tags: Antimicrobial Resistance, ITFAR, CDC, antibiotics, NIH, Meeting, Latest News

Bill Proposes National Tracking System for Drug Overdoses By Alexander Gaffney - Published 21 August 2012

Tags: Overdose, Sentinel System, Edwards, CDC, Surveillance, Legislation, House, Opioids, Latest News, Bill, pharmaceutical, drug

After Flu Concerns, Regulators Look to Issue Guidelines on 'Dual Use' Preclinical Studies By Alexander Gaffney - Published 12 April 2012

Categories: FDA, WHO, Preclinical

Tags: H5N1, Bird Flu, BSL4, BSL3, Biosafety, Biodefense, CDC, Flu, Latest News, research, disease

FDA Gets New COO By Alexander Gaffney - Published 12 April 2012

Categories: FDA

Tags: Chief Operating Officer, CDC, Harris, COO, Latest News, Hamburg, leadership