iwewlkws Do we need fewer regulations? Who should point out which ones should go? Who is the target of this reduction in regulation, the industry or the healthcare community? The U.S. Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) announced a major new initiative this week whereby the public can … Read more
The FDA audits, particularly the unannounced or surprise inspections, are critical to ensure the integrity of the global drug supply chains. Unannounced FDA inspections at foreign facilities pose unique logistical, legal, and cultural challenges, leading to most foreign audits being announced weeks before they occur. This week, the FDA announced that it will expand unannounced … Read more
The executive order signed by President Donald J. Trump to promote American-made prescription drugs addresses a real and pressing issue. However, it oversimplifies the economic and structural factors behind the offshoring of drug manufacturing and misrepresents the nature of what kinds of pharmaceuticals are produced abroad versus domestically. The decision-making process for pharmaceutical manufacturing is … Read more
Imagine a future where the data generated in clinical trials doesn’t vanish at study closeout but continues to yield insights for years. Picture clinical evidence that integrates real-world outcomes, slashing data collection costs while boosting trial power and relevance. A scoping review shows how linking clinical trials to real-world data (RWD) can increase the reliability … Read more
Biomedical research is undergoing a paradigm shift as the National Institutes of Health (NIH) unveils a transformative initiative this week to accelerate the adoption of human-specific, non-animal models in its research programs, both internal and external. The NIH would strongly encourage the use of advanced technologies such as organoids, tissue chips, computational systems, and real-world … Read more
The Prescription Drug User Fee Act (PDUFA), enacted in 1992, has transformed the U.S. drug approval process by providing the FDA with essential funding from biopharmaceutical companies. Critics often argue that this funding creates conflicts of interest, claiming it “corrupts” the FDA. One such narrative is presented in another book published this week, which misrepresents … Read more
Clinical trials with high-risk medical devices frequently involve historical controls and other criteria as concurrent control groups in such studies are not feasible or ethical. A survey of about 100 high-risk medical devices approved by the FDA over five years shows some interesting trends in using non-concurrent controls in medical device trials. Between 2019 and … Read more
Collecting data from both male and female volunteers is critical for appropriate evaluation of clinical trial outcomes. FDA’s latest guidance document outlines what the FDA expects when it comes to enrolling male and female participants, analyzing results by sex, and sharing this information in clinical study reports. Although this issue has been discussed extensively for … Read more
The FDA has announced the strengthening of a law signed in 2022 to reduce animal testing by creating a formal policy to require the use of AI models, lab-grown human tissues or organelles, and international safety data, if available, to replace traditional animal testing. The “shift” aims to “improve accuracy, reduce costs, and accelerate the … Read more
The laboratory testing industry is breathing a collective sigh of relief this week after a federal court struck down the Food and Drug Administration’s (FDA) final rule aimed at increasing regulatory oversight of laboratory-developed tests (LDTs). This ruling marks a significant victory for labs, who argued that the FDA overstepped its authority in attempting to … Read more
