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Wave of Warning Letters to Foreign OTC Drug Manufacturing Facilities Following Remote Records Requests

FDA Law Blog

Instead, FDA issued a request for records pursuant to Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA). Section 704(a)(4) was added to the FDCA by the Food and Drug Administration Safety and Innovation Action (FDASIA) in July 2012.

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The Clinical Study Protocol: The Basics

Cloudbyz

Typically, a study protocol has the following sections: Note: This ordering is general and can be rearranged to what appropriately fits your study. 1) Protocol Summary : This section is a synopsis of the study protocol document. 4) Study Design : The study design section overviews how the research will be conducted.

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Enhancement, Efficiency, Equity, and Engagement: Four Trends Shaping Clinical Trials in 2024

ACRP blog

These high rates are influenced by financial, emotional, and logistical barriers to participation, such as geographic location and travel-related costs, which prevent patients from enrolling in trials and accessing life-changing medicine.

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Field Application Scientist Jobs: Everything You Need to Know

XTalks

They are expected to travel to customer sites to share their profound knowledge about the specific tool or service that needs to be applied in the laboratory. Product installation and demonstration of use: This is where a lot of travelling is involved. However, they would need to keep up with the latest product innovations.

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Monoclonal antibody could transform malaria prevention

Drug Discovery World

These study results suggest that a monoclonal antibody could potentially complement other measures to protect travellers and vulnerable groups such as infants, children, and pregnant women from seasonal malaria and help eliminate malaria from defined geographical areas.” . Urgent need for new interventions. Trials in more potent antibody.

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Positive results for US Malaria vaccine, trial shows 

Drug Discovery World

“A one-time intervention that protects against malaria for six months to a year could significantly reduce morbidity and mortality among children in malaria-endemic regions and offer an effective preventive tool for health care workers, military personnel and travellers to these areas.” ? .

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BIOGEN TO WEBCAST ADUCANUMAB PRESENTATIONS FROM AD/PD 2021 VIRTUAL CONFERENCE ON MARCH 9-13, 2021

The Pharma Data

To access the webcasts, please go to the Investors section of Biogen’s website at investors.biogen.com. To access the webinar, please go to the Investors section of Biogen’s website at investors.biogen.com. Please note all pre-recorded presentation webcasts will be available online on March 9, 2021, starting at 2:00 a.m.