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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

The coronavirus pandemic has FDA on its toes, not just to get as many products to diagnose, treat or prevent COVID-19 to the patients, but also to rein in opportunists and scam artists who want to monetize on the crisis by selling fake and unreliable products. An emergency does not mean that the regulators are … Read more

The burning question in all circles of the society is when and how would a treatment or vaccine for COVID-19 emerge. The politicians and public would want it done in days and weeks, the scientists and developers need months and years. The vaccine is projected to take at least about 12-18 months to be ready … Read more

The Indian government took several measures to protect its population from COVID-19, among them a ban of export of any products needed to manage the pandemic such as masks, PPE, ventilators, and chloroquine. The export ban for selected items by the Indian government is designed to prevent price gauging and to assure that sufficient supplies … Read more

This week Gilead’s decision to ask FDA to rescind its orphan drug designation for its COVID-19 drug highlighted the loophole in the overall rules for orphan drug designations. Unlike all other expedited approval designations, orphan drugs designations (ODD), once granted by the FDA cannot be rescinded by the FDA, under almost all circumstances. Gilead reportedly … Read more

In the last few years, the nutritional labels for foods have gone through major revisions. Proper nutrition is critically dependent on the consumer’s ability to understand the nutritional content of the food they consume. And it is even more important in times of limited mobility such as these days with the travel and movement restrictions … Read more

Most ongoing clinical trials in the US have been suspended indefinitely, and no new trials are being initiated due to the COVID-19 pandemic. FDA advices measures like those implemented during a temporary clinical hold in such circumstances. With shelter at home advisory and mandatory quarantine in place in most places in the country, clinics must … Read more

Research INDs, sponsored mostly by academic centers, are exempt from electronic submission and, hence, are mostly filed in traditional paper format. FDA now wants even those INDs to follow the Common Technical Document (CTD) format and submit electronically via the Electronic Submission Gateway (ESG) but would exempt them from the electronic CTD requirements, namely the … Read more