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 Unlike all other expedited approval designations, orphan drugs designations (ODD), once granted by the FDA cannot be rescinded by the FDA, under almost all circumstances.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
FDA announced this week that it is cancelling all scheduled foreign inspections and limit domestic travel only to mission critical functions essentially stopping all inspection activities to address the spread of coronavirus infection. This is an extension of last week’s announcement where FDA cancelled all inspections in China. During this time, FDA would rely on … Read more
This week FDA approved the first generic drug version of Daraprim. This drug was made famous about 5 years ago when a company increased its price by 5000% almost overnight due to a manufacturing monopoly and the CEO of the company, Martin Shkreli, became the poster-boy of bad pricing and illegal business practices. The fact … Read more
World’s response to COVID-19, the flu-like disease caused by the latest strain of coronavirus, highlights key aspects of how we would handle any potential pandemic. Although most of the measures to control the spread, rapid diagnosis, and management of the disease have been taken by the Chinese government where the disease originated and has caused … Read more
