Prahsant Kumar FDA has increasingly relied on remote inspections of manufacturing facilities since March 2020. It announced resumption of the normal on-site inspections a few times since then and then re-paused on-site inspections due to the pandemic. Earlier this year, FDA had announced a similar pause in on-site inspections due to the spread of the omicron strain … Read more
FDA would like clinical trials using remote data collection devices such as wearable gadgets and phone apps to consider five factors that may influence the reliability and acceptability of the data generated. The devices or apps (software) must be diligently selected to assure it is suitable for the expected data, it should be verified and … Read more
Facebook will stop offering a few popular tools for targeted advertising of clinical trials to potential participants soon. The tools together called “Detailed Targeting” allows presenting targeted advertisements to patients based on health conditions. These changes may affect trials that depend primarily on social media for finding patients such as cancer studies, neurological disorders and … Read more
The clinicaltrials.gov website is undergoing modernization to be more user friendly and mobile optimized. The new website will evolve over the next year. It starts this week with a beta version which is an optional format for now as you can go back to the “classic” version. In a year’s time, the “classic” version will … Read more
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
