The European Commission's (EC) Medical Device Coordination Group (MDCG) has provided a set of templates to fulfill European Medical Device Regulation (MDR) requirements on submitting clinical investigation application and notification documents in the absence of the European database on medical devices (EUDAMED).
In a rare move, the FDA disclosed summary trial information May 17 about Cytodyn Inc.’s Vyrologix (leronlimab), noting that currently available data don’t support the clinical benefit of the drug as a COVID-19 treatment.
Since joining the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use in 2017, China has approved clinical trials and marketing of drugs a lot faster with simultaneous clinical development at home and abroad.
The FDA’s May 4 webinar on patient data generated over the course of the product life cycle covered a number of topics, including the use of social media as a source of real-world evidence (RWE). The FDA’s Anne Hammer said, however, that while social media engagement has exploded over the past couple of decades, issues such as data duplication and verifiability will have to be resolved before patient engagement via social media can be relied upon as a source of RWE for regulatory purposes.
The FDA’s May 4 webinar on patient data generated over the course of the product life cycle covered a number of topics, including the use of social media as a source of real-world evidence (RWE). The FDA’s Anne Hammer said, however, that while social media engagement has exploded over the past couple of decades, issues such as data duplication and verifiability will have to be resolved before patient engagement via social media can be relied upon as a source of RWE for regulatory purposes.
Drug and device companies dragging their feet on diversifying late-stage clinical trials could conceivably get a wake-up call in court or in FDA approval delays.
Drug and device companies dragging their feet on diversifying late-stage clinical trials could conceivably get a wake-up call in court or in FDA approval delays. A final guidance the FDA released in November suggests that the days of ignoring segments of the intended treatment population until safety signals flare in real-world use are coming to an end.
The U.S. NIH’s Feb. 17 announcement that it’s funding a study of the effects of remdesivir in treating COVID-19 in pregnant women is welcome news, but it begs the question of why it took so long given the risk of more severe disease in that population.
Investing in biopharma has never been for the faint of heart. So headline figures unveiled from a clinical development success report during the BIO CEO & Investor Conference Feb. 17, putting the average likelihood of a drug entering phase I development ultimately achieving approval at 7.9% and the average drug development timeline at 10.5 years, appear largely unsurprising. But the addition of machine learning capabilities to the mix helped identify those factors that have the greatest impact on predictive outcome.
Aside from its place in the history books as a global pandemic that nearly locked down the world, COVID-19 could have a lasting, more positive legacy of finally opening U.S. biopharmaceutical clinical trials to greater diversity.