iwewlkws This week FDA announced that it is going to require emergency use authorizations (EUA) for Lab Developed Tests (LDTs) intended for Covid diagnosis summarily reversing a decision last August that LDTs don’t need EUA. While this may seem like a major decision, it is not. The announcement is very specific to RT-PCR tests for Covid, … Read more
Real world data (RWD) and the resulting real world evidence (RWE) can provide unique and valuable information, otherwise hard to generate, on best practices for patient treatment in real-world health care settings. FDA supported two RWD studies, one in adults and the other in pediatric populations, to evaluate the duration of the antibiotic treatments for … Read more
Most cancer drugs are clinically evaluated at the highest dose possible, the Maximum Tolerated Dose (MTD), with the assumption that more is better. A white paper co-authored by several FDA oncology drug officials argues that the MTD approach is no longer appropriate and that prior to conducting registration studies, sponsors should conduct dose-finding studies to … Read more
FDA has several programs for assuring food safety and often publishes on various food safety initiatives. But USDA and CDC also play in role in regulating food supply and monitoring for food-borne infections. An article this week describes how despite multiple regulations and programs, several food-borne illnesses go unchecked. According to CDC, about 48 million … Read more
Companies developing new drugs often hire outside subject matter experts (SMEs) to advise on the development strategies, build scientific consensus, and advocate for the product to others. And the SMEs are compensated for their time. But does getting paid for their time compromise the integrity of the SMEs? A news item floating in the media … Read more
Although FDA has approved about 343 medical devices using Artificial Intelligence (AI) and Machine Learning (ML) technologies, a much larger number of devices using such technologies are used in general health awareness applications and do not require FDA’s review or approval for launch. These are mostly apps or software that collect data about real world … Read more
Vaccines have overwhelmingly dominated the public and regulatory attention since the beginning of the pandemic. Most of the public funding and resources seems to have been devoted to developing effective vaccines rather than therapies. And it has worked, for the vaccines. While we have several vaccines for Covid and billions of people worldwide have been … Read more
Just like human drugs, animal drugs can also be approved based on real world evidence available from veterinary records. However, there are several issues to be considered for creating sufficient supportive real world data for animal drug approval applications. A new FDA guidance released this week discusses the nuances of the real world data (RWD) … Read more
The rapid increase in digital medicine products is leading to flawed products that could hurt patients using them, according to a report from the Brookings Institute this week. The report states that the core technology behind such products, “affective computing” or “emotionally intelligent computing”, remains in its infancy and is being introduced improperly “without scientific … Read more
Clinical trials conducted to support market approval of new drugs must follow a quality by design (QbD) approach where each clinical study, included in the market approval application, identifies factors that were critical to the quality of the study and how those risks were managed during study conduct. A new guidance from ICH released this … Read more
