News about Global Pharma

FDA issues warning letters to two breast implant manufacturers as part of ongoing efforts to protect patients

FDA issues warning letters to two breast implant manufacturers as part of ongoing efforts to protect patients

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with various regulatory requirements

Global Pharma | 15/05/2020 | By Darshana

Merck?s foundational CRISPR-Cas9 technology receives US patnet

Merck?s foundational CRISPR-Cas9 technology receives US patnet

Merck, a leading science and technology company, announced that two of its CRISPR-Cas9-assisted genome-editing patents have been allowed in the United States

Global Pharma | 12/05/2020 | By Darshana

FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients

FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients

The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic

Global Pharma | 10/05/2020 | By Darshana

FDA Continues to Combat Fraudulent COVID-19 Medical Products

FDA Continues to Combat Fraudulent COVID-19 Medical Products

Today, the U.S. Food and Drug Administration is providing an update on the agency?s efforts to combat the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic

Global Pharma | 08/05/2020 | By Darshana

Cleveland Clinic establishes center for global and emerging pathogens research

Cleveland Clinic establishes center for global and emerging pathogens research

Cleveland Clinic is establishing the Center for Global and Emerging Pathogens Research to broaden understanding of emerging pathogens ? ranging from Zika virus to SARS-CoV-2 (which causes COVID-19) ? and to expedite critically needed treatments and vaccines

Global Pharma | 04/05/2020 | By Darshana

Revive Therapeutics gets US FDA recommendation tostart phase 3 trial of Bucillamine to treat COVID-19

Revive Therapeutics gets US FDA recommendation tostart phase 3 trial of Bucillamine to treat COVID-19

Revive Therapeutics, a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced that it has received positive feedback from the US Food and Drug Administration (FDA) in response to the company?s Pre-Investigational New Drug (pre-IND) meeting

Global Pharma | 25/04/2020 | By Darshana

WHO issue new guidance on use of ferritin concentrations to assess iron deficiency and protect brain development

WHO issue new guidance on use of ferritin concentrations to assess iron deficiency and protect brain development

Detecting iron deficiency early during pregnancy and in young children is crucial. Iron deficiency in children under two years of age can have significant and irreversible effects on brain development. This can lead to negative consequences on learning and school performance later in life

Global Pharma | 22/04/2020 | By Darshana

European regulators issue guidance on regulatory requirements in the context of COVID-19 pandemic

European regulators issue guidance on regulatory requirements in the context of COVID-19 pandemic

The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients

Global Pharma | 13/04/2020 | By Darshana

Bayer to boost Germany's COVID-19 analysis capacity by several thousand tests per day

Bayer to boost Germany's COVID-19 analysis capacity by several thousand tests per day

Bayer is undertaking further measures to support the fight against the coronavirus pandemic. At various sites in Germany, the company is making available more than 40 virus diagnostics devices from its research operations, enabling Germany's COVID-19 analysis capacity to be increased by several thousand tests daily

Global Pharma | 31/03/2020 | By Darshana

FDA expedites review of diagnostic tests to combat COVID-19

FDA expedites review of diagnostic tests to combat COVID-19

The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA?s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic

Global Pharma | 31/03/2020 | By Darshana

 
 

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