Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from ...
The FDA is considering imposing financial penalties on researchers who submit false data to the government’s clinical trials database, according to a draft guidance posted to the Federal Register Sept ...
The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...
Detect pharmaceutical IP theft, ransomware campaigns, and supply chain breaches in real time with Morpheus AI SOC. The post ...
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Opinion: FDA should judge drugs on what they do in real life, not just in companies’ clinical trials
Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of ...
Please provide your email address to receive an email when new articles are posted on . FDA issued guidance on decentralized elements of clinical trials last fall. Investigators need to balance using ...
As rare disease trials face persistent feasibility challenges, Bayesian designs are gaining momentum by enabling more ...
Diversity in clinical trials matters for drug safety and efficacy—and for future medical advancements. Clinical trial ...
Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of ...
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