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
A detailed analysis of all articles submitted for publication to a leading medical journal over the last two years by the Editor-in-Chief saw that in most cases authors were unable to provide raw data to their articles when requested, raising doubts about the authenticity and credibility of the data being presented for publication. Although 97% … Read more
Electronic health records (EHRs) related administrative and regulatory burdens cause increased physician burnouts and leading to loss of productivity. A report by the DHHS’s Health IT office released this week lists ways to reduce the effort and time required to record information in EHRs, reduce the effort and time required to meet regulatory reporting requirements, … Read more
There is a video circulating on social media claiming that FDA allows significant amounts of filthy content in common foods such as cockroach parts, rat hair, and animal excreta in chocolate, mold and insect eggs in orange juice, insect larvae in corn, and so on. There is some truth in this statement, but it is … Read more
Last year, Vanda Pharmaceuticals sued FDA for putting its clinical trial on partial hold for lack of nonclinical data from dog studies. This week, a federal court ruled that FDA has the authority to ask for any additional data that FDA’s reviewers deem necessary to lift the clinical hold. The court further ruled that Vanda … Read more
As hospital and insurance systems monetize their patient databases by selling data to information companies like Google, they should share some of the financial rewards with the patients to avoid being accused of exploiting patient data for personal gains, according to ethicists as the University of Pennsylvania. Google and other information technology companies are acquiring … Read more
Patient presentations at FDA Advisory Committee meetings are very important for swaying the votes of reluctant jurors to vote in favor of approval. Almost none of the patient presentations are against the drug under review and all of them are paid for by the company who product is being debated by the Advisory Committee. A … Read more
