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.
Key Factors Driving Medical Writing Outsourcing Strategy – I
CSOFT Health Sciences SVP Dr. Nimita Limaye has taken the time to answer some questions from our guest audience about the medical writing industry. In her first interview, she focuses on key factors that cause businesses to outsource their medical writing needs. Jane:...
FDA Amends Policy for Covid Tests
The FDA announced that it would strengthen its oversight for companies marketing the Covid 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 Covid Treatment 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. This authorization will allow the distribution of the drug all over the US, as well as...
FDA Announces Exemptions and Exclusions from Certain Requirements in the Drug Supply Chain Security Act
Yesterday (4/30) the FDA lifted some of the security requirements in the Drug Supply Chain Security Act to help expedite adequate distribution of prescription drugs due to COVID-19. These exemptions and exclusions apply to...
Amazing Cooperation Between Companies to Meet Global Demands in Global Supply Chains for Pandemic-Response Equipment
There has been amazing cooperation by companies with global supply chains to come together during Covid and produce surplus PPE and ventilators for domestic and international markets. Communicating effectively across multi-lingual global supply chains is more...
FDA Gives Guidance on Bioequivalence Studies for Submission Amidst Covid
The FDA released guidance on Tuesday (4/28) for bioequivalence studies intended for submission in Abbreviated New Drug Applications (ANDAs). Due to Covid, many clinical trial studies have been negatively impacted due to travel limitations, site closures, etc. With...
EU Gives Five New Guidances for Medical Devices
The European Commission's Medical Device Coordination Group (MDCG) posted five new guidances on Friday (4/24) for medical devices in light of COVID-19. These guidances are used when demonstrating equivalence to existing devices,...
EU Unanimously Votes to Delay EU MDR by 1 Year
In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to the EU MDR by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of the new system, while also...
Covid, Ebola, and Typhoid, Oh My!: 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 Covid self-quarantine has brought...
The Effects of Cabin Fever
Staying at home for extended periods of time, also known as "cabin fever", can feel like entrapment. Especially true for those accustomed to a hyper-connected lifestyle, quarantining can be detrimental to one’s well-being. Not being able to attend a dance class in...
FDA Authorizes First At-Home Covid Testing Kits
Yesterday (4/21) the FDA announced EUA for at-home Covid testing kits from LabCorp. These nasal swab tests were previously authorized in mid-March by the FDA, however only for medical professionals to use. Stephen Hahn, FDA Commissioner, released in a statement that...
MemorialCare Long Beach Center Joins Global Fight Against Covid
As part of an ongoing global study, MemorialCare Long Beach Center has administered the antiviral drug Remdesivir to three patients as a possible treatment for Covid. This news comes closely after Gilead, a biotech company based out of the California Bay Area,...
FDA Allows Outsourcing for Drugs in Short Supply Due to Covid
The FDA announced on Thursday (4/16) it was temporarily allowing compounding for necessary hospital drugs due to the mass shortage from Covid. The majority of the 13 commonly used drugs listed in the policy are anesthetic or analgesic drugs, which helps support...
“Must Wear Masks”: Covid and the Spanish Flu
Before Covid, wearing a mask in a supermarket in the United States or in Britain might have earned uneasy glances from fellow shoppers. Are you sick, or is there something you’re trying to hide? Now, that is all changing. With the America’s CDC now recommending...
AAMI Drafts Emergency Respirator and Ventilator Medical Devices Guidance in Response to Shortage Due to COVID-19
The Association for the Advancement of Medical Instrumentation (AAMI) released four guidelines yesterday (4/14) from their COVID-19 response team about medical device such as respirators and ventilators to help combat the viral outbreak. The team is made up of...
How Can We Deal With Stress?
This article is part 3 of a mini-series focusing on how the body can combat stressors. This final instalment dives into several techniques for reducing stress and how they can positively impact the body. In this mini-series we have gone over what stress does to the...
Face Masks, Social Distancing, and Sheltering in Place: The New Landscape of Global Health in the Fight Against Covid
As Covid continues to spread across the globe, affecting Italy, Spain, and the United States most severely, governmental agencies continue to fight the spread of misinformation surrounding the virus by issuing health safety recommendations. The importance of social...
The Mysterious Relationship Between Mental Health and Stress
This article is part 2 of a mini-series focusing on how the body reacts to stressors. This installment explores the importance of mental health awareness and how stress can deteriorate our mental health. Mental health awareness has become an incredibly important topic...
Medical Device Regulation: The Need for Global Harmonization
The medical device industry is one of the most complex and rapidly evolving sectors of the health sciences field. Dynamic innovation in medical devices has helped better healthcare both in terms of people’s quality of life and their longevity; however, while the value...