FDA announced this week that it will no longer hold in-person meetings. All previously scheduled in-person meetings have been converted to phone meetings or written responses only. Many meeting requests will be delayed and may be denied. Among the impacts of the pandemic, this change will perhaps bite the most for the regulated industry that … Read more
About a month ago, it was being predicted that a treatment for COVID-19 may take several months and a vaccine may not be available for 12-18 months. These predictions got kicked with the emergency approval of Gilead’s remdesivir, and positive results from Moderna’s vaccine trial run by NIH, and this is not by chance. Both … Read more
Physicians are often coaxed by their patients to try the latest product approved by FDA or in the news. However, before a treatment decision is made, one must understand the clinical data that was used to support the market approval. While placebo-controlled studies may be the gold standard for the FDA approval of a given … Read more
Patients suffering from untreatable diseases could be helped by experimental treatments being evaluated in clinical trials. However, it is hard for most such patients to find well-matched clinical trials and to assure their enrollment in the same. What if the patient decides to fund a given clinical trial on themselves? Is it legal and is … Read more
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
