iwewlkws Clinical Outcome Assessments (COAs) are the measures of the clinical response to a treatment as observed by a patient, their physician, an independent observer, or an objective measure of the patient’s performance following treatment with a drug or biologic. COAs are closely related to patient focused drug development where clinically relevant outcomes can and have … Read more
Why is there only one diagnostic test for Covid cleared by FDA under the 510k pathway after almost 2 years of the pandemic? FDA has granted emergency use authorizations (EUA) to 423 Covid tests, but it has only given one device 510k clearance, that too in March of this year, 9 months ago. The 510k … Read more
For those who have tried, sending a Freedom of Information (FOI) request to FDA is like dropping a coin in a wishing well and then hoping for your prayers to be answered. FDA recently provided a rare glimpse into its FOI process in response to a court case and it would come as no surprise … Read more
Does it matter that the FDA’s top leader has cozy relationships with the industry he regulates? Would it influence the policies he proposes, and would those policies still give patient and public interest the same weight as that of the for-profit industry? These are reasonable questions to ask when anyone takes on any role at … Read more
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
