The COVID-19 pandemic has shifted the FDA’s approach to real-world evidence (RWE) in a positive light, according to Stacy Cline Amin, former chief counsel of the FDA. Although the 21st Century Cures Act of 2016 opened the door to implementation of RWE for approval of new indications in previously […]
Will Rob Califf’s industry ties sink his FDA commissioner nomination?
Dr. Rob Califf’s extensive industry ties cast uncertainty on his nomination for FDA commissioner. The nominee’s financial disclosures, released this week reveal that his industry ties grew since leaving the position in 2016. In a report by Zachary Brennan, senior editor of Endpoints News, Califf […]
Navigating the FDA Real-Time Oncology Review Process for Sponsors
Started in 2018, the FDA’s “Real-Time Oncology Review (ROTR)” project gives sponsors a head start on the application review process and poses additional challenges. The ROTR helps sponsors plan around anticipated FDA results immediately to begin preparing their full submission package […]
New Report Considers Use of Oncology RWE in Successful Submissions to the FDA
In a recent article published in Clinical Cancer Research, investigators analyzed successful submissions of oncology drugs to the Food and Drug Administration (FDA) that utilized real world evidence (RWE). The researchers identified elements criticized by the FDA, including confounding factors, and […]
Biden Picks Califf As Safe Bet for FDA Commissioner
Biden has nominated Robert Califf to lead the Food and Drug Administration (FDA). Although Califf’s position at Google’s Verily has drawn some criticism, pharmaceutical companies largely support his appointment. “President Joe Biden’s final choice is one both the industry and agency insiders have […]
MDIC Webinar on Cybersecurity and Medical Devices
The Medical Device Innovation Consortium (MDIC) has released an on-demand webinar on modeling cybersecurity threats for medical devices. The Food and Drug Administration (FDA) recognizes the dangers associated with medical devices and has developed bootcamps in collaboration with MDIC. “To […]
Podcast on Clinical Trial Challenges and FDA Solutions
A recent episode of the Business of Biotech podcast series features Allan Shaw. This installment highlights some of the major problems arising from clinical trials, along with possible solutions. “The clinical trials status quo is a roadblock. They're slow, they're inefficient, and they're […]
Robert Califf’s Ties to Big Tech Bring Scrutiny
Could Robert Califf lead the Food and Drug Administration (FDA)? Not until he explains his ties to technology companies. It’s not the first time he’s been scrutinized for his attachment to industry; he also holds connections to pharma. “But now, if President Biden puts him forth to lead the FDA […]
Aetion Publishes 2021 eBook Showcasing RWE in Successful FDA Submissions
Aetion has published an eBook following an investigation into when and how real world evidence (RWE) successfully supports submissions to the Food and Drug Administration (FDA). The eBook explores RWE across therapeutic areas and identifies factors that influence external control arms. “Aetion […]
FDA Directors Discuss EUAs, Transparency, and COVID-19
In a recent meeting, Food and Drug Administration directors discussed how emergency use authorizations (EUAs) affected the response to the COVID-19 pandemic. FDA officials also discussed possible changes to the EUA mechanism. “The flexibility of emergency use authorizations, and allowing the FDA […]
