Social distancing, frequent screening, extra hygienic practices and limited services are some of the precautions listed on FDA’s checklist for all restaurants planning to re-open for service. One big loophole; all guidelines are for the employees, no requirements for patrons. Which leaves it up to a given establishment to create rules for its customers. It … Read more
The Emergency Use Authorization (EUA) is a very important tool for fighting special circumstances but the COVID-19 emergency has exposed that these can be exploited financially by bad players. Since the declaration of the emergency, FDA has relaxed several rules governing personal protection equipment (PPEs) and, more importantly, the diagnostic tests. A unique policy announced … Read more
There are more than 1000 clinical trials currently ongoing to evaluate various aspects of COVID-19, creating a pressure for recruiting patients and raising questions about the negative effects of the over-competition. But that may not be a fair question to ask. With more than 3.1 million confirmed infections and 228,000 deaths, there is unique sense … Read more
The Department of Health and Human Services (HHS), the governing body over the FDA, rescinded FDA’s guidance documents regarding the need for pre-market approval or emergency use authorization for Laboratory Developed diagnostic tests (LDTs). LDTs are widely used and have been in a regulatory limbo for many years because of contradictory FDA announcements. FDA has … Read more
The NIH put together a panel of all major government and professional organizations to create COVID-19 treatment guidelines and the outcome was a report that strongly “does not recommend” any of the treatment options tested or used so far in patients and offers a bleak perspective of the status of the disease management. It basically … Read more
With more than 850,000 confirmed cases and more than 47,000 death from COVID-19 in the US alone, the pandemic has overwhelmed practically all aspects of our healthcare and life. But there is a silver lining. Although there is yet no approved therapy, the patients infected with the coronavirus are being managed by their physicians and … Read more
Typically, an IND application requires months and years of research and development, and a reasonable rationale for the potential treatment. Since the announcement of the pandemic about 2-3 months ago, there have been hundreds of clinical trials initiated for products intended to treat or prevent the disease. This may seem like an awfully short time … Read more
The “Stay at Home” orders have created a once-in-a-lifetime opportunity for information tech companies to build and test digital health tools that would live way beyond the pandemic. All those concerns for privacy and of digital health companies exploiting our personal health information for their financial gains have gone out the window while government, political … Read more
In about 3 weeks since FDA announced a policy under which serological tests could be sold with just a notification of intent to file an EUA, more than 70 companies have filed this notification and started selling diagnostic tests that measure anti-coronavirus antibodies. However, these tests must carry a disclaimer that the test has not … Read more
In the last two months, FDA has announced, proposed, and implemented several measures to address the ongoing pandemic, but questions are being raised about the perceived slow speed at which FDA acts in an emergency. There have been complaints of FDA taking too long to authorize diagnostic tests and making decisions on the Emergency Use … Read more
