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CSOFT’s health sciences blog aims to provide a better understanding of complex diseases, and regulatory polices from conducting experiments to introducing new type of drugs into the market.

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FDA Releases Guidance on Formal Meetings Amid COVID-19 Crisis

The FDA announced on Wednesday (5/27) new guidances via a Q&A format for how COVID-19 is impacting formal meetings, effective immediately. The guidance outlines that all meetings with the FDA will be held remotely, either through teleconference or video...

EMA Strengthens ENCePP Madate Due to COVID-19

The European Medical Association (EMA) has strengthened the mandate for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).  Currently, the mandate works to strengthen how the risks and benefits of medicinal products...

Remote Devices: A New Age of Patient Centricity

A new age of patient centricity has dawned, and the need for remote patient engagement has become more crucial than ever. From being able to remotely visit COVID-19 patients, to continuously tracking patients participating in clinical trials, remote technology helps...

Moderna Notes Early Signs of Success in COVID-19 Vaccine

Today (5/18) Moderna announced that its clinical trial in the United States has started to see protective antibodies in data from 8 healthy individuals, chosen at random from a 45-person study. The study, which began in March, and found that the...

Authoring a Clinical Study Protocol – I

Continuing her interview series, Dr. Nimita Limaye further answers questions from our guest audience members surrounding medical writing practices for clinical study protocols. She focuses on the role a medical writer plays in the process of writing these strategic...

Moderna Moves into Phase 2 of COVID-19 Vaccine

In their business update, Moderna announced they received FDA clearance to move into Phase 2 of their study for the COVID-19 vaccine. In their press release, they also reported additional funding from Biomedical Advanced Research and Development Authority (BARDA) as...

Exploring the World of Vaccinations

Explore the world of vaccinations with Professor K in understanding what they are, how they work, and the challenges they face in development and implementation, especially for COVID-19.

FDA Amends Policy for COVID-19 Tests

The FDA announced that it would strengthen its oversight for companies marketing the COVID-19 serology tests. After questions came to light in regards to the accuracy of some of the testing kits, the FDA is now requiring commercial manufacturers to submit an emergency...

FDA Grants EUA for Remdesivir from Gilead

The FDA announced today (5/1) that it would grant EUA for Gilead for their antiviral drug remdesivir for treatment in early response to suspected or confirmed patients with COVID-19. This authorization will allow the distribution of the drug all over the US, as well...

EU Unanimously Votes to Delay MDR by 1 Year

In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to Medical Device Regulation by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of...

A Tale of Global Pandemics

This article is part 1 of a mini-series focusing on the progression of global pandemics. This instalment explores the history of past pandemics and how they relate to the current COVID-19 situation. While it may seem that our current self-quarantine has brought upon...